CompletedPhase 2Results posted

A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

Lead sponsor

AbbVie

Asset

Tilavonemab

Listed sites

Recruiting sites

Enrollment

453

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)•MMSE 22-30•Study partner/caregiver required

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Treatment Emergent Adverse Events (TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2016-001634-10

Org study IDM15-566

NCT IDNCT02880956

Timeline

Milestones

Study first posted2016-08-26estimated

Study start2017-01-26actual

Primary completion2021-03-30actual

Study completion2021-07-28actual

Last update posted2022-08-26actual

Results first posted2022-08-26actual

Assets

Drug assets

Tilavonemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

-Clinical Dementia Rating (CDR)-Global Score of 0.5

-Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive

-Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower

•Subject has a positive amyloid positron emission tomography (PET) scan.

•Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.

•The subject has an identified, reliable, study partner (e.g., family member).

•If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization

Exclusion criteria

•Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.

•Subject has evidence of any other clinically significant neurological disorder other than early AD.

•In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.

•Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

Endpoints (94)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Behavior / neuropsychiatric

Other (unclassified)

Function / daily living

Global cognition

64 endpoints

Primary/protocol endpoint

Change From Baseline Over Time in CDR-SB Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Change From Baseline Over Time in CDR-SB Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=110 Participants	0.60	0.125
Change to Week 48n=105 Participants	1.06	0.155
Change to Week 72n=100 Participants	1.90	0.213
Change to Week 96n=85 Participants	2.54	0.271
ABBV-8E12 300 mgChange to Week 24n=108 Participants	0.66	0.129
Change to Week 48n=97 Participants	1.15	0.161
Change to Week 72n=93 Participants	1.88	0.220
Change to Week 96n=85 Participants	2.47	0.277
ABBV-8E12 1000 mgChange to Week 24n=116 Participants	0.44	0.125
Change to Week 48n=105 Participants	1.05	0.154
Change to Week 72n=101 Participants	1.85	0.212
Change to Week 96n=91 Participants	2.48	0.267
ABBV-8E12 2000 mgChange to Week 24n=113 Participants	0.63	0.130
Change to Week 48n=98 Participants	0.99	0.161
Change to Week 72n=95 Participants	1.81	0.219
Change to Week 96n=81 Participants	2.70	0.279

Least Squares (LS) Mean of Difference0.0695% CI-0.291 - 0.409p0.740repeated measures model

Week 24

Effect size/pooled SD-0.04

Week 24

LS Mean of Difference-0.1695% CI-0.504 - 0.187p0.367repeated measures model

Week 24

Effect size/pooled SD0.12

Week 24

LS Mean of Difference0.0495% CI-0.318 - 0.389p0.843repeated measures model

Week 24

Effect size/pooled SD-0.03

Week 24

LS Mean of Difference0.0895% CI-0.351 - 0.520p0.703repeated measures model

Week 48

Effect size/pooled SD-0.05

Week 48

LS Mean of Difference-0.0195% CI-0.442 - 0.413p0.947repeated measures model

Week 48

Effect size/pooled SD-0.01

Week 48

LS Mean of Difference-0.0895% CI-0.514 - 0.361p0.732repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference-0.0295% CI-0.623 - 0.576p0.939repeated measures model

Week 72

Effect size/pooled SD0.01

Week 72

LS Mean of Difference-0.0595% CI-0.637 - 0.540p0.872repeated measures model

Week 72

Effect size/pooled SD0.02

Week 72

LS Mean of Difference-0.0995% CI-0.688 - 0.512p0.773repeated measures model

Week 72

Effect size/pooled SD0.04

Week 72

LS Mean of Difference-0.0795% CI-0.834 - 0.686p0.848repeated measures model

Week 96

Effect size/pooled SD0.03

Week 96

LS Mean of Difference-0.0695% CI-0.810 - 0.684p0.869repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

LS Mean of Difference0.1695% CI-0.603 - 0.925p0.679repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Commands Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=104 Participants	1.82	0.492
Change at Week 48n=98 Participants	4.50	0.621
Change at Week 72n=91 Participants	5.26	0.718
Change at Week 96n=72 Participants	8.43	0.898
ABBV-8E12 300 mgChange at Week 24n=103 Participants	1.42	0.498
Change at Week 48n=89 Participants	3.51	0.642
Change at Week 72n=88 Participants	4.78	0.730
Change at Week 96n=78 Participants	7.99	0.891
ABBV-8E12 1000 mgChange at Week 24n=110 Participants	0.56	0.480
Change at Week 48n=102 Participants	3.42	0.605
Change at Week 72n=92 Participants	5.00	0.706
Change at Week 96n=77 Participants	7.84	0.872
ABBV-8E12 2000 mgChange at Week 24n=99 Participants	1.86	0.503
Change at Week 48n=87 Participants	4.03	0.647
Change at Week 72n=85 Participants	6.37	0.738
Change at Week 96n=64 Participants	9.46	0.935

LS Mean of Difference-0.4095% CI-1.764 - 0.960p0.562repeated measures model

Week 24

Effect size/pooled SD0.08

Week 24

LS Mean of Difference-1.2695% CI-2.602 - 0.081p0.066repeated measures model

Week 24

Effect size/pooled SD0.25

Week 24

LS Mean of Difference0.0395% CI-1.343 - 1.410p0.962repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.9995% CI-2.734 - 0.755p0.265repeated measures model

Week 48

Effect size/pooled SD0.16

Week 48

LS Mean of Difference-1.0895% CI-2.775 - 0.618p0.212repeated measures model

Week 48

Effect size/pooled SD0.17

Week 48

LS Mean of Difference-0.4795% CI-2.223 - 1.290p0.602repeated measures model

Week 48

Effect size/pooled SD0.07

Week 48

LS Mean of Difference-0.4895% CI-2.489 - 1.519p0.635repeated measures model

Week 72

Effect size/pooled SD0.08

Week 72

LS Mean of Difference-0.2695% CI-2.233 - 1.712p0.795repeated measures model

Week 72

Effect size/pooled SD0.04

Week 72

LS Mean of Difference1.1195% CI-0.910 - 3.128p0.281repeated measures model

Week 72

Effect size/pooled SD-0.16

Week 72

LS Mean of Difference-0.4495% CI-2.918 - 2.043p0.729repeated measures model

Week 96

Effect size/pooled SD0.06

Week 96

LS Mean of Difference-0.5995% CI-3.047 - 1.863p0.636repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

LS Mean of Difference1.0395% CI-1.515 - 3.575p0.427repeated measures model

Week 96

Effect size/pooled SD-0.13

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Comprehension of Spoken Language Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.01	0.038
Change at Week 48n=102 Participants	0.03	0.044
Change at Week 72n=100 Participants	0.17	0.064
Change at Week 96n=81 Participants	0.30	0.083
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.03	0.038
Change at Week 48n=92 Participants	0.09	0.046
Change at Week 72n=92 Participants	0.11	0.066
Change at Week 96n=81 Participants	0.26	0.083
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.04	0.037
Change at Week 48n=105 Participants	0.07	0.044
Change at Week 72n=96 Participants	0.14	0.064
Change at Week 96n=87 Participants	0.19	0.080
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.08	0.039
Change at Week 48n=93 Participants	0.12	0.046
Change at Week 72n=95 Participants	0.31	0.066
Change at Week 96n=76 Participants	0.29	0.085

LS Mean of Difference0.0295% CI-0.083 - 0.126p0.690repeated measures model

Week 24

Effect size/pooled SD-0.05

Week 24

LS Mean of Difference0.0395% CI-0.075 - 0.131p0.595repeated measures model

Week 24

Effect size/pooled SD-0.08

Week 24

LS Mean of Difference0.0795% CI0.037 - 0.175p0.201repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference0.0695% CI-0.067 - 0.184p0.361repeated measures model

Week 48

Effect size/pooled SD-0.12

Week 48

LS Mean of Difference0.0495% CI-0.082 - 0.162p0.522repeated measures model

Week 48

Effect size/pooled SD-0.10

Week 48

LS Mean of Difference0.0995% CI-0.033 - 0.219p0.147repeated measures model

Week 48

Effect size/pooled SD-0.17

Week 48

LS Mean of Difference-0.0695% CI-0.243 - 0.117p0.492repeated measures model

Week 72

Effect size/pooled SD0.11

Week 72

LS Mean of Difference-0.0495% CI-0.213 - 0.141p0.691repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference0.1495% CI-0.043 - 0.317p0.135repeated measures model

Week 72

Effect size/pooled SD-0.19

Week 72

LS Mean of Difference-0.0495% CI-0.273 - 0.187p0.713repeated measures model

Week 96

Effect size/pooled SD0.06

Week 96

LS Mean of Difference-0.1195% CI-0.341 - 0.111p0.318repeated measures model

Week 96

Effect size/pooled SD0.14

Week 96

LS Mean of Difference-0.0195% CI-0.244 - 0.222p0.927repeated measures model

Week 96

Effect size/pooled SD0.01

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Constructional Praxis Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.11	0.057
Change at Week 48n=102 Participants	0.07	0.073
Change at Week 72n=100 Participants	0.25	0.069
Change at Week 96n=80 Participants	0.41	0.089
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.05	0.058
Change at Week 48n=92 Participants	0.23	0.077
Change at Week 72n=92 Participants	0.22	0.072
Change at Week 96n=81 Participants	0.25	0.089
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	-0.02	0.056
Change at Week 48n=105 Participants	0.17	0.072
Change at Week 72n=96 Participants	0.16	0.070
Change at Week 96n=86 Participants	0.026	0.086
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.09	0.059
Change at Week 48n=93 Participants	0.20	0.077
Change at Week 72n=94 Participants	0.16	0.071
Change at Week 96n=75 Participants	0.33	0.092

LS Mean of Difference-0.0695% CI-0.219 - 0.098p0.456repeated measures model

Week 24

Effect size/pooled SD0.09

Week 24

LS Mean of Difference-0.1395% CI-0.290 - 0.023p0.093repeated measures model

Week 24

Effect size/pooled SD0.23

Week 24

LS Mean of Difference-0.0395% CI-0.187 - 0.135p0.750repeated measures model

Week 24

Effect size/pooled SD0.04

Week 24

LS Mean of Difference0.1695% CI-0.049 - 0.366p0.134repeated measures model

Week 48

Effect size/pooled SD-0.20

Week 48

LS Mean of Difference0.1095% CI-0.099 - 0.305p0.316repeated measures model

Week 48

Effect size/pooled SD-0.14

Week 48

LS Mean of Difference0.1395% CI-0.078 - 0.339p0.218repeated measures model

Week 48

Effect size/pooled SD-0.17

Week 48

LS Mean of Difference-0.0395% CI-0.219 - 0.169p0.799repeated measures model

Week 72

Effect size/pooled SD0.04

Week 72

LS Mean of Difference-0.0895% CI-0.273 - 0.111p0.406repeated measures model

Week 72

Effect size/pooled SD0.11

Week 72

LS Mean of Difference-0.0995% CI-0.285 - 0.105p0.363repeated measures model

Week 72

Effect size/pooled SD0.12

Week 72

LS Mean of Difference-0.1595% CI-0.400 - 0.093p0.220repeated measures model

Week 96

Effect size/pooled SD0.18

Week 96

LS Mean of Difference-0.1495% CI-0.386 - 0.099p0.245repeated measures model

Week 96

Effect size/pooled SD0.17

Week 96

LS Mean of Difference-0.0795% CI-0.323 - 0.178p0.569repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Commands Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.09	0.066
Change at Week 48n=102 Participants	0.17	0.072
Change at Week 72n=100 Participants	0.09	0.078
Change at Week 96n=81 Participants	0.30	0.102
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.10	0.067
Change at Week 48n=92 Participants	0.12	0.076
Change at Week 72n=92 Participants	0.11	0.081
Change at Week 96n=81 Participants	0.36	0.103
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.09	0.065
Change at Week 48n=105 Participants	0.09	0.071
Change at Week 72n=96 Participants	0.36	0.079
Change at Week 96n=86 Participants	0.40	0.100
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.09	0.068
Change at Week 48n=93 Participants	0.22	0.075
Change at Week 72n=95 Participants	0.21	0.080
Change at Week 96n=76 Participants	0.40	0.106

LS Mean of Difference0.0195% CI-0.177 - 0.190p0.945repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.0095% CI-0.184 - 0.178p0.974repeated measures model

Week 24

Effect size/pooled SD0.00

Week 24

LS Mean of Difference-0.0095% CI-0.190 - 0.181p0.963repeated measures model

Effect size/pooled SD0.01

Week 24

LS Mean of Difference-0.0595% CI-0.255 - 0.154p0.625repeated measures model

Week 48

Effect size/pooled SD0.07

Week 48

LS Mean of Difference-0.0795% CI-0.272 - 0.125p0.468repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference0.0595% CI-0.155 - 0.254p0.636repeated measures model

Week 48

Effect size/pooled SD-0.06

Week 48

LS Mean of Difference0.0295% CI-0.204 - 0.236p0.887repeated measures model

Week 72

Effect size/pooled SD-0.02

Week 72

LS Mean of Difference0.2795% CI0.051 - 0.486p0.016repeated measures model

Week 72

Effect size/pooled SD-0.33

Week 72

LS Mean of Difference0.1295% CI-0.097 - 0.342p0.272repeated measures model

Week 72

Effect size/pooled SD-0.15

Week 72

LS Mean of Difference0.0695% CI-0.223 - 0.347p0.671repeated measures model

Week 96

Effect size/pooled SD-0.07

Week 96

LS Mean of Difference0.1095% CI-0.183 - 0.378p0.493repeated measures model

Week 96

Effect size/pooled SD-0.11

Week 96

LS Mean of Difference0.1095% CI-0.190 - 0.387p0.501repeated measures model

Week 96

Effect size/pooled SD-0.10

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Delayed Word Recall Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=109 Participants	0.11	0.133
Change at Week 48n=101 Participants	0.41	0.133
Change at Week 72n=99 Participants	0.39	0.132
Change at Week 96n=79 Participants	0.86	0.135
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.17	0.135
Change at Week 48n=92 Participants	0.30	0.138
Change at Week 72n=92 Participants	0.61	0.136
Change at Week 96n=81 Participants	0.80	0.135
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	-0.04	0.131
Change at Week 48n=105 Participants	0.32	0.131
Change at Week 72n=96 Participants	0.52	0.133
Change at Week 96n=86 Participants	0.60	0.131
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	-0.09	0.137
Change at Week 48n=93 Participants	0.27	0.138
Change at Week 72n=95 Participants	0.67	0.135
Change at Week 96n=76 Participants	0.66	0.138

LS Mean of Difference0.0695% CI-0.307 - 0.431p0.742repeated measures model

Week 24

Effect size/pooled SD-0.04

Week 24

LS Mean of Difference-0.1595% CI-0.511 - 0.218p0.431repeated measures model

Week 24

Effect size/pooled SD0.10

Week 24

LS Mean of Difference-0.2095% CI-0.574 - 0.172p0.290repeated measures model

Week 24

effect size0.13

Week 24

LS Mean of Difference-0.1295% CI-0.492 - 0.258p0.541repeated measures model

Week 48

Effect size/pooled SD0.08

Week 48

LS Mean of Difference-0.0995% CI-0.459 - 0.272p0.617repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.1495% CI-0.517 - 0.233p0.457repeated measures model

Week 48

Effect size/pooled SD0.09

Week 48

LS Mean of Difference0.2295% CI-0.151 - 0.590p0.245repeated measures model

Week 72

Effect size/pooled SD-0.15

Week 72

LS Mean of Difference0.1395% CI-0.238 - 0.496p0.491repeated measures model

Week 72

Effect size/pooled SD-0.08

Week 72

LS Mean of Difference0.2895% CI-0.085 - 0.652p0.132repeated measures model

Week 72

Effect size/pooled SD-0.18

Week 72

LS Mean of Difference-0.0695% CI-0.434 - 0.313p0.751repeated measures model

Week 96

Effect size/pooled SD0.04

Week 96

LS Mean of Difference-0.2795% CI-0.635 - 0.103p0.157repeated measures model

Week 96

Effect size/pooled SD0.16

Week 96

LS Mean of Difference-0.2195% CI-0.585 - 0.172p0.283repeated measures model

Week 96

Effect size/pooled SD0.14

Week 24

Secondary/protocol endpoint

Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Ideational Praxis Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.05	0.057
Change at Week 48n=102 Participants	0.21	0.075
Change at Week 72n=99 Participants	0.18	0.083
Change at Week 96n=80 Participants	0.35	0.111
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.13	0.058
Change at Week 48n=92 Participants	0.12	0.078
Change at Week 72n=92 Participants	0.25	0.086
Change at Week 96n=81 Participants	0.26	0.112
ABBV-8E12 1000 mgChange at Week 24n=112 Participants	0.02	0.056
Change at Week 48n=105 Participants	0.09	0.073
Change at Week 72n=96 Participants	0.21	0.083
Change at Week 96n=86 Participants	0.41	0.108
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.18	0.059
Change at Week 48n=93 Participants	0.16	0.078
Change at Week 72n=94 Participants	0.35	0.085
Change at Week 96n=75 Participants	0.42	0.114

LS Mean of Difference0.0795% CI-0.085 - 0.231p0.363repeated measures model

Week 24

Effect size/pooled SD-0.11

Week 24

LS Mean of Difference-0.0395% CI-0.188 - 0.124p0.688repeated measures model

Week 24

Effect size/pooled SD0.05

Week 24

LS Mean of Difference0.1295% CI-0.039 - 0.281p0.137repeated measures model

Week 24

Effect size/pooled SD-0.18

Week 24

LS Mean of Difference-0.0995% CI-0.300 - 0.122p0.408repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference-0.1295% CI-0.325 - 0.085p0.249repeated measures model

Week 48

Effect size/pooled SD0.15

Week 48

LS Mean of Difference-0.0595% CI-0.265 - 0.157p0.616repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference0.0795% CI-0.163 - 0.304p0.555repeated measures model

Week 72

Effect size/pooled SD-0.08

Week 72

LS Mean of Difference0.0395% CI-0.203 - 0.258p0.815repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference0.1895% CI-0.057 - 0.409p0.138repeated measures model

Week 72

Effect size/pooled SD-0.20

Week 72

LS Mean of Difference-0.0995% CI-0.397 - 0.220p0.573repeated measures model

Week 96

Effect size/pooled SD0.09

Week 96

LS Mean of Difference0.0695% CI-0.241 - 0.365p0.689repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

LS Mean of Difference0.0795% CI-0.243 - 0.382p0.662repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Maze Task Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=107 Participants	0.15	0.130
Change at Week 48n=100 Participants	0.37	0.147
Change at Week 72n=97 Participants	0.32	0.160
Change at Week 96n=74 Participants	0.52	0.184
ABBV-8E12 300 mgChange at Week 24n=104 Participants	-0.04	0.132
Change at Week 48n=89 Participants	0.07	0.154
Change at Week 72n=89 Participants	0.14	0.166
Change at Week 96n=80 Participants	0.29	0.181
ABBV-8E12 1000 mgChange at Week 24n=111 Participants	-0.20	0.129
Change at Week 48n=104 Participants	0.21	0.145
Change at Week 72n=93 Participants	0.04	0.162
Change at Week 96n=80 Participants	0.60	0.179
ABBV-8E12 2000 mgChange at Week 24n=101 Participants	0.17	0.134
Change at Week 48n=88 Participants	0.28	0.155
Change at Week 72n=88 Participants	0.40	0.167
Change at Week 96n=70 Participants	0.52	0.190

LS Mean of Difference-0.1995% CI-0.555 - 0.167p0.291repeated measures model

Week 24

Effect size/pooled SD0.13

Week 24

Effect size/pooled SD-0.3695% CI-0.713 - 0.001p0.051repeated measures model

Week 24

Effect size/pooled SD0.23

Week 24

LS Mean of Difference0.0295% CI-0.346 - 0.383p0.921repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.3095% CI-0.711 - 0.120p0.163repeated measures model

Week 48

Effect size/pooled SD0.18

Week 48

LS Mean of Difference-0.1695% CI-0.567 - 0.239p0.424repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference-0.0995% CI-0.510 - 0.326p0.664repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.1995% CI-0.638 - 0.265p0.417repeated measures model

Week 72

Effect size/pooled SD0.11

Week 72

LS Mean of Difference-0.2895% CI-0.727 - 0.166p0.217repeated measures model

Week 72

Effect size/pooled SD0.17

Week 72

LS Mean of Difference0.0795% CI-0.381 - 0.526p0.753repeated measures model

Week 72

Effect size/pooled SD-0.04

Week 72

LS Mean of Difference-0.2395% CI-0.740 - 0.270p0.362repeated measures model

Week 96

Effect size/pooled SD0.14

Week 96

LS Mean of Difference0.0795% CI-0.432 - 0.575p0.780repeated measures model

Week 96

Effect size/pooled SD-0.04

Week 96

LS Mean of Difference-0.0195% CI-0.526 - 0.509p0.974repeated measures model

Week 96

Effect size/pooled SD0.01

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Number Cancellation Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=107 Participants	0.33	0.099
Change at Week 48n=99 Participants	0.43	0.114
Change at Week 72n=95 Participants	0.75	0.115
Change at Week 96n=76 Participants	0.87	0.138
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.33	0.100
Change at Week 48n=92 Participants	0.42	0.118
Change at Week 72n=92 Participants	0.68	0.117
Change at Week 96n=80 Participants	0.84	0.137
ABBV-8E12 1000 mgChange at Week 24n=112 Participants	0.35	0.097
Change at Week 48n=103 Participants	0.42	0.112
Change at Week 72n=93 Participants	0.44	0.115
Change at Week 96n=83 Participants	0.74	0.133
ABBV-8E12 2000 mgChange at Week 24n=100 Participants	0.32	0.102
Change at Week 48n=92 Participants	0.22	0.118
Change at Week 72n=91 Participants	0.68	0.118
Change at Week 96n=70 Participants	0.77	0.143

LS Mean of Difference0.0095% CI-0.269 - 0.278p0.976repeated measures model

Week 24

Effect size/pooled SD-0.00

Week 24

LS Mean of Difference0.0395% CI-0.244 - 0.296p0.850repeated measures model

Week 24

Effect size/pooled SD-0.02

Week 24

LS Mean of Difference-0.0095% CI-0.281 - 0.275p0.981repeated measures model

Week 24

Effect size/pooled SD0.00

Week 24

LS Mean of Difference-0.0095% CI-0.323 - 0.318p0.989repeated measures model

Week 48

Effect size/pooled SD0.00

Week 48

LS Mean of Difference-0.0195% CI-0.319 - 0.307p0.970repeated measures model

Week 48

effect size0.00

Week 48

LS Mean of Difference-0.2095% CI-0.526 - 0.119p0.215repeated measures model

Week 48

Effect size/pooled SD0.17

Week 48

LS Mean of Difference-0.0795% CI-0.392 - 0.250p0.665repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference-0.3195% CI-0.625 - 0.012p0.059repeated measures model

Week 72

Effect size/pooled SD0.28

Week 72

LS Mean of Difference-0.0795% CI-0.394 - 0.251p0.663repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference-0.0395% CI-0.413 - 0.348p0.866repeated measures model

Week 96

Effect size/pooled SD0.03

Week 96

LS Mean of Difference-0.1495% CI-0.514 - 0.238p0.471repeated measures model

Week 96

Effect size/pooled SD0.11

Week 96

LS Mean of Difference-0.1095% CI-0.493 - 0.287p0.604repeated measures model

Week 96

Effect size/pooled SD0.09

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Naming Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=108 Participants	0.02	0.048
Change at Week 48n=101 Participants	0.11	0.049
Change at Week 72n=97 Participants	0.21	0.063
Change at Week 96n=79 Participants	0.34	0.085
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.08	0.049
Change at Week 48n=92 Participants	0.09	0.051
Change at Week 72n=92 Participants	0.14	0.065
Change at Week 96n=80 Participants	0.34	0.086
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	-0.03	0.047
Change at Week 48n=105 Participants	0.08	0.048
Change at Week 72n=96 Participants	0.08	0.063
Change at Week 96n=86 Participants	0.28	0.082
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.05	0.050
Change at Week 48n=93 Participants	0.03	0.050
Change at Week 72n=95 Participants	0.07	0.064
Change at Week 96n=75 Participants	0.20	0.087

LS Mean of Difference0.0795% CI-0.067 - 0.202p0.325repeated measures model

Week 24

Effect size/pooled SD-0.12

Week 24

LS Mean of Difference-0.0495% CI-0.177 - 0.088p0.510repeated measures model

Week 24

Effect size/pooled SD0.10

Week 24

LS Mean of Difference0.0495% CI-0.100 - 0.172p0.601repeated measures model

Week 24

Effect size/pooled SD-0.07

Week 24

LS Mean of Difference-0.0295% CI-0.157 - 0.119p0.783repeated measures model

Week 48

Effect size/pooled SD0.04

Week 48

LS Mean of Difference-0.0395% CI-0.165 - 0.103p0.646repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.0995% CI-0.226 - 0.050p0.209repeated measures model

Week 48

Effect size/pooled SD0.18

Week 48

LS Mean of Difference-0.0795% CI-0.246 - 0.110p0.454repeated measures model

Week 72

Effect size/pooled SD0.10

Week 72

LS Mean of Difference-0.1395% CI-0.306 - 0.043p0.141repeated measures model

Week 72

Effect size/pooled SD0.23

Week 72

LS Mean of Difference-0.1595% CI-0.323 - 0.031p0.107repeated measures model

Week 72

Effect size/pooled SD0.24

Week 72

LS Mean of Difference-0.0195% CI-0.243 - 0.232p0.961repeated measures model

Week 96

Effect size/pooled SD0.01

Week 96

LS Mean of Difference-0.0695% CI-0.290 - 0.173p0.618repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

LS Mean of Difference-0.1595% CI-0.385 - 0.092p0.227repeated measures model

Week 96

Effect size/pooled SD0.18

Week 96

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Orientation Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.08	0.127
Change at Week 48n=102 Participants	0.63	0.147
Change at Week 72n=100 Participants	1.01	0.166
Change at Week 96n=80 Participants	1.26	0.196
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.42	0.130
Change at Week 48n=92 Participants	0.77	0.154
Change at Week 72n=92 Participants	0.84	0.172
Change at Week 96n=81 Participants	1.46	0.197
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.08	0.125
Change at Week 48n=105 Participants	0.45	0.145
Change at Week 72n=96 Participants	1.02	0.167
Change at Week 96n=86 Participants	1.28	0.191
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.49	0.132
Change at Week 48n=93 Participants	0.61	0.153
Change at Week 72n=95 Participants	1.05	0.171
Change at Week 96n=76 Participants	2.00	0.202

LS Mean of Difference0.3495% CI-0.009 - 0.697p0.056repeated measures model

Week 24

Effect size/pooled SD-0.23

Week 24

LS Mean of Difference0.0095% CI-0.348 - 0.349p0.997repeated measures model

Week 24

Effect size/pooled SD-0.00

Week 24

LS Mean of Difference0.4195% CI0.056 - 0.772p0.023repeated measures model

Week 24

Effect size/pooled SD-0.30

Week 24

LS Mean of Difference0.1495% CI-0.274 - 0.558p0.502repeated measures model

Week 48

Effect size/pooled SD-0.09

Week 48

LS Mean of Difference-0.1895% CI-0.587 - 0.224p0.379repeated measures model

Week 48

Effect size/pooled SD0.11

Week 48

LS Mean of Difference-0.0295% CI-0.439 - 0.394p0.916repeated measures model

Week 48

Effect size/pooled SD0.01

Week 48

LS Mean of Difference-0.1795% CI-0.633 - 0.302p0.487repeated measures model

Week 72

Effect size/pooled SD0.10

Week 72

LS Mean of Difference0.0195% CI-0.451 - 0.473p0.963repeated measures model

Week 72

Effect size/pooled SD-0.01

Week 72

LS Mean of Difference0.0495% CI-0.424 - 0.510p0.856repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference0.2095% CI-0.341 - 0.748p0.463repeated measures model

Week 96

Effect size/pooled SD-0.11

Week 96

LS Mean of Difference0.0295% CI-0.518 - 0.557p0.943repeated measures model

Week 96

Effect size/pooled SD-0.01

Week 96

LS Mean of Difference0.7495% CI0.191 - 1.295p0.009repeated measures model

Week 96

Effect size/pooled SD-0.38

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Word Recall - Number of Words Not Recalled Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.16	0.098
Change at Week 48n=102 Participants	0.39	0.101
Change at Week 72n=100 Participants	0.58	0.113
Change at Week 96n=81 Participants	1.04	0.131
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.03	0.100
Change at Week 48n=92 Participants	0.32	0.105
Change at Week 72n=92 Participants	0.64	0.117
Change at Week 96n=81 Participants	0.97	0.132
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.16	0.097
Change at Week 48n=105 Participants	0.41	0.100
Change at Week 72n=96 Participants	0.60	0.114
Change at Week 96n=88 Participants	0.89	0.127
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.11	0.101
Change at Week 48n=93 Participants	0.38	0.105
Change at Week 72n=94 Participants	0.70	0.116
Change at Week 96n=76 Participants	0.91	0.135

LS Mean of Difference-0.1495% CI-0.408 - 0.136p0.325repeated measures model

Week 24

Effect size/pooled SD0.13

Week 24

LS Mean of Difference-0.0195% CI-0.274 - 0.263p0.966repeated measures model

Week 24

Effect size/pooled SD0.01

Week 24

LS Mean of Difference-0.0595% CI-0.330 - 0.220p0.695repeated measures model

Week 24

Effect size/pooled SD0.05

Week 24

LS Mean of Difference-0.0695% CI-0.348 - 0.221p0.662repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference0.0395% CI-0.250 - 0.304p0.849repeated measures model

Week 48

Effect size/pooled SD-0.03

Week 48

LS Mean of Difference-0.0095% CI-0.286 - 0.284p0.995repeated measures model

Week 48

Effect size/pooled SD0.00

Week 48

LS Mean of Difference0.0695% CI-0.256 - 0.378p0.707repeated measures model

Week 72

Effect size/pooled SD-0.05

Week 72

LS Mean of Difference0.0295% CI-0.294 - 0.333p0.901repeated measures model

Week 72

Effect size/pooled SD-0.02

Week 72

LS Mean of Difference0.1295% CI-0.195 - 0.439p0.451repeated measures model

Week 72

Effect size/pooled SD-0.11

Week 72

LS Mean of Difference-0.0795% CI-0.429 - 0.298p0.722repeated measures model

Week 96

Effect size/pooled SD0.06

Week 96

LS Mean of Difference-0.1595% CI-0.503 - 0.210p0.420repeated measures model

Week 96

Effect size/pooled SD0.12

Week 96

LS Mean of Difference-0.1395% CI-0.495 - 0.241p0.498repeated measures model

Week 96

Effect size/pooled SD0.11

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Coding Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Remember Word Recognition Instructions Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.03	0.050
Change at Week 48n=102 Participants	0.27	0.071
Change at Week 72n=100 Participants	0.24	0.091
Change at Week 96n=80 Participants	0.40	0.112
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.03	0.051
Change at Week 48n=92 Participants	0.10	0.074
Change at Week 72n=92 Participants	0.19	0.094
Change at Week 96n=81 Participants	0.45	0.113
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.15	0.049
Change at Week 48n=105 Participants	0.19	0.070
Change at Week 72n=96 Participants	0.29	0.091
Change at Week 96n=82 Participants	0.27	0.111
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	-0.02	0.052
Change at Week 48n=93 Participants	0.06	0.074
Change at Week 72n=95 Participants	0.26	0.093
Change at Week 96n=72 Participants	0.46	0.117

LS Mean of Difference0.0095% CI-0.138 - 0.142p0.975repeated measures model

Week 24

Effect size/pooled SD-0.00

Week 24

LS Mean of Difference0.1295% CI-0.014 - 0.261p0.078repeated measures model

Week 24

Effect size/pooled SD-0.19

Week 24

LS Mean of Difference-0.0595% CI-0.188 - 0.094p0.514repeated measures model

Week 24

Effect size/pooled SD0.10

Week 24

LS Mean of Difference-0.1795% CI-0.367 - 0.036p0.107repeated measures model

Week 48

Effect size/pooled SD0.23

Week 48

LS Mean of Difference-0.0895% CI-0.275 - 0.116p0.425repeated measures model

Week 48

Effect size/pooled SD0.09

Week 48

LS Mean of Difference-0.2195% CI-0.413 - -0.011p0.039repeated measures model

Week 48

Effect size/pooled SD0.28

Week 48

LS Mean of Difference-0.0595% CI-0.302 - 0.212p0.729repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference0.0595% CI-0.198 - 0.307p0.671repeated measures model

Week 72

Effect size/pooled SD-0.06

Week 72

LS Mean of Difference0.0295% CI-0.235 - 0.276p0.876repeated measures model

Week 72

Effect size/pooled SD-0.02

Week 72

LS Mean of Difference0.0595% CI-0.266 - 0.362p0.763repeated measures model

Week 96

Effect size/pooled SD-0.04

Week 96

LS Mean of Difference-0.1295% CI-0.434 - 0.185p0.429repeated measures model

Week 96

Effect size/pooled SD0.12

Week 96

LS Mean of Difference0.0695% CI-0.256 - 0.381p0.701repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Digit Span Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Spoken Language Ability Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.07	0.045
Change at Week 48n=102 Participants	0.14	0.051
Change at Week 72n=100 Participants	0.23	0.066
Change at Week 96n=81 Participants	0.29	0.089
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.08	0.046
Change at Week 48n=92 Participants	0.04	0.054
Change at Week 72n=92 Participants	0.11	0.069
Change at Week 96n=81 Participants	0.23	0.090
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.06	0.045
Change at Week 48n=105 Participants	0.03	0.051
Change at Week 72n=96 Participants	0.19	0.066
Change at Week 96n=87 Participants	0.25	0.087
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.11	0.047
Change at Week 48n=93 Participants	0.11	0.053
Change at Week 72n=95 Participants	0.24	0.068
Change at Week 96n=76 Participants	0.43	0.092

LS Mean of Difference0.0195% CI-0.115 - 0.137p0.867repeated measures model

Week 24

Effect size/pooled SD-0.02

Week 24

LS Mean of Difference-0.0195% CI-0.132 - 0.116p0.898repeated measures model

Week 24

Effect size/pooled SD0.02

Week 24

LS Mean of Difference0.0495% CI-0.088 - 0.168p0.537repeated measures model

Week 24

Effect size/pooled SD-0.07

Week 24

LS Mean of Difference-0.1095% CI-0.245 - 0.045p0.176repeated measures model

Week 48

Effect size/pooled SD0.15

Week 48

LS Mean of Difference-0.1195% CI-0.251 - 0.031p0.125repeated measures model

Week 48

Effect size/pooled SD0.21

Week 48

LS Mean of Difference-0.0395% CI-0.176 - 0.114p0.676repeated measures model

week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference-0.1295% CI-0.301 - 0.071p0.226repeated measures model

Week 72

Effect size/pooled SD0.18

Week 72

LS Mean of Difference-0.0495% CI-0.222 - 0.145p0.683repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference0.0295% CI-0.168 - 0.204p0.848repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference-0.0695% CI-0.305 - 0.192p0.656repeated measures model

Week 96

Effect size/pooled SD0.07

Week 96

LS Mean of Difference-0.0495% CI-0.279 - 0.209p0.777repeated measures model

Week 96

Effect size/pooled SD0.04

Week 96

LS Mean of Difference0.1595% CI-0.106 - 0.397p0.256repeated measures model

Week 96

Effect size/pooled SD-0.16

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Figure Copy Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Word Find Difficulty Spontaneous Speech Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.21	0.071
Change at Week 48n=102 Participants	0.25	0.077
Change at Week 72n=100 Participants	0.47	0.093
Change at Week 96n=81 Participants	0.58	0.117
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.14	0.073
Change at Week 48n=92 Participants	0.19	0.081
Change at Week 72n=92 Participants	0.28	0.096
Change at Week 96n=81 Participants	0.35	0.119
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	0.11	0.070
Change at Week 48n=105 Participants	0.21	0.077
Change at Week 72n=96 Participants	0.44	0.094
Change at Week 96n=87 Participants	0.47	0.114
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	0.23	0.074
Change at Week 48n=93 Participants	0.31	0.081
Change at Week 72n=95 Participants	0.42	0.096
Change at Week 96n=76 Participants	0.60	0.121

LS Mean of Difference-0.0795% CI-0.269 - 0.126p0.479repeated measures model

Week 24

Effect size/pooled SD0.09

Week 24

LS Mean of Difference-0.1095% CI-0.299 - 0.091p0.295repeated measures model

Week 24

Effect size/pooled SD0.13

Week 24

LS Mean of Difference0.0195% CI-0.186 - 0.215p0.884repeated measures model

Week 24

Effect size/pooled SD-0.02

Week 24

LS Mean of Difference-0.0695% CI-0.281 - 0.155p0.569repeated measures model

Week 48

Effect size/pooled SD0.08

Week 48

Effect size/pooled SD-0.0495% CI-0.254 - 0.171p0.702repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference0.0695% CI-0.155 - 0.283p0.566repeated measures model

Week 48

Effect size/pooled SD-0.07

Week 48

LS Mean of Difference-0.2095% CI-0.458 - 0.065p0.141repeated measures model

Week 72

Effect size/pooled SD0.22

Week 72

LS Mean of Difference-0.0395% CI-0.285 - 0.230p0.834repeated measures model

Week 72

Effect size/pooled SD0.03

Week 72

LS Mean of Difference-0.0595% CI-0.309 - 0.215p0.724repeated measures model

Week 72

Effect size/pooled SD0.05

Week 72

LS Mean of Difference-0.2395% CI-0.559 - 0.095p0.163repeated measures model

Week 96

Effect size/pooled SD0.24

Week 96

LS Mean of Difference-0.1195% CI-0.432 - 0.210p0.497repeated measures model

Week 96

effect size0.10

Week 96

LS Mean of Difference0.0295% CI-0.314 - 0.349p0.919repeated measures model

Week 96

Effect size/pooled SD-0.01

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Figure Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADAS-Cog-14 Word Recognition Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=110 Participants	0.53	0.248
Change at Week 48n=102 Participants	1.35	0.257
Change at Week 72n=100 Participants	0.65	0.245
Change at Week 96n=80 Participants	1.98	0.287
ABBV-8E12 300 mgChange at Week 24n=106 Participants	0.25	0.253
Change at Week 48n=92 Participants	0.92	0.270
Change at Week 72n=92 Participants	1.05	0.255
Change at Week 96n=81 Participants	1.97	0.287
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	-0.20	0.245
Change at Week 48n=105 Participants	0.73	0.254
Change at Week 72n=96 Participants	0.78	0.249
Change at Week 96n=82 Participants	1.53	0.283
ABBV-8E12 2000 mgChange at Week 24n=102 Participants	-0.02	0.257
Change at Week 48n=93 Participants	0.80	0.268
Change at Week 72n=95 Participants	0.88	0.252
Change at Week 96n=72 Participants	2.09	0.301

LS Mean of Difference-0.2895% CI-0.974 - 0.409p0.423repeated measures model

Week 24

Effect size/pooled SD0.09

Week 24

LS Mean of Difference-0.7395% CI-1.408 - -0.047p0.036repeated measures model

Week 24

Effect size/pooled SD0.25

Week 24

LS Mean of Difference-0.5595% CI-1.250 - 0.147p0.121repeated measures model

Week 24

Effect size/pooled SD0.18

Week 24

LS Mean of Difference-0.4395% CI-1.163 - 0.296p0.244repeated measures model

Week 48

Effect size/pooled SD0.15

Week 48

LS Mean of Difference-0.6295% CI-1.330 - 0.086p0.085repeated measures model

Week 48

Effect size/pooled SD0.21

Week 48

LS Mean of Difference-0.5595% CI-1.280 - 0.177p0.137repeated measures model

Week 48

Effect size/pooled SD0.19

Week 48

LS Mean of Difference0.4095% CI-0.294 - 1.091p0.258repeated measures model

Week 72

Effect size/pooled SD-0.14

Week 72

LS Mean of Difference0.1395% CI-0.555 - 0.814p0.711repeated measures model

Week 72

Effect size/pooled SD-0.04

Week 72

LS Mean of Difference0.2495% CI-0.454 - 0.924p0.503repeated measures model

Week 72

Effect size/pooled SD-0.08

Week 72

LS Mean of Difference-0.0195% CI-0.806 - 0.784p0.978repeated measures model

Week 96

Effect size/pooled SD0.00

Week 96

LS Mean of Difference-0.4595% CI-1.239 - 0.342p0.265repeated measures model

Week 96

Effect size/pooled SD0.14

Week 96

LS Mean of Difference0.1195% CI-0.704 - 0.925p0.789repeated measures model

Week 96

Effect size/pooled SD-0.04

Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - List Recognition Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - List Learning Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Line Orientation Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in ADCS-CGIC-MCI Cognition Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 48n=99 Participants	4.85	0.080
Change at Week 96n=83 Participants	5.30	0.092
ABBV-8E12 300 mgChange at Week 48n=95 Participants	4.81	0.081
Change at Week 96n=83 Participants	5.29	0.092
ABBV-8E12 1000 mgChange at Week 48n=104 Participants	4.83	0.077
Change at Week 96n=89 Participants	5.22	0.088
ABBV-8E12 2000 mgChange at Week 48n=95 Participants	4.92	0.081
Change at Week 96n=80 Participants	5.34	0.093

LS Mean of Difference-0.0495% CI-0.260 - 0.180p0.722repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference-0.0295% CI-0.232 - 0.198p0.878repeated measures model

Week 48

Effect size/pooled SD0.02

Week 48

LS Mean of Difference0.0795% CI-0.151 - 0.290p0.535repeated measures model

Week 48

Effect size/pooled SD-0.09

Week 48

Effect size/pooled SD-0.0195% CI-0.266 - 0.239p0.916repeated measures model

Week 96

Effect size/pooled SD0.01

Week 96

LS Mean of Difference-0.0895% CI-0.330 - 0.165p0.511repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

LS Mean of Difference0.0495% CI-0.217 - 0.292p0.771repeated measures model

Week 96

Effect size/pooled SD-0.04

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - List Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Picture Naming Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Story Memory Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in RBANS - Story Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Repeatable Battery for Assessment of Neuropsychological Status (RBANS) - Total Scale Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=108 Participants	-3.52	0.640
Change to Week 48n=98 Participants	-1.85	0.757
Change to Week 72n=94 Participants	-5.27	0.861
Change to Week 96n=74 Participants	-6.79	0.923
ABBV-8E12 300 mgChange to Week 24n=105 Participants	-4.83	0.649
Change to Week 48n=90 Participants	-1.37	0.782
Change to Week 72n=87 Participants	-5.95	0.885
Change to Week 96n=75 Participants	-7.78	0.928
ABBV-8E12 1000 mgChange to Week 24n=107 Participants	-5.04	0.637
Change to Week 48n=101 Participants	-1.86	0.746
Change to Week 72n=90 Participants	-6.86	0.862
Change to Week 96n=79 Participants	-6.59	0.901
ABBV-8E12 2000 mgChange to Week 24n=100 Participants	-5.17	0.664
Change to Week 48n=88 Participants	-2.67	0.792
Change to Week 72n=86 Participants	-6.38	0.897
Change to Week 96n=64 Participants	-7.03	0.977

LS Mean of Difference-1.3195% CI-3.080 - 0.465p0.148repeated measures model

Week 24

Effect size/pooled SD-0.19

Week 24

LS Mean of Difference-1.5295% CI-3.278 - 0.246p0.092repeated measures model

Week 24

Effect size/pooled SD-0.21

Week 24

LS Mean of Difference-1.6595% CI-3.446 - 0.152p0.073repeated measures model

Week 24

Effect size/pooled SD-0.25

Week 24

LS Mean of Difference0.4795% CI-1.652 - 2.599p0.662repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.0195% CI-2.089 - 2.068p0.992repeated measures model

Week 48

Effect size/pooled SD-0.00

Week 48

LS Mean of Difference-0.8295% CI-2.961 - 1.320p0.451repeated measures model

Week 48

Effect size/pooled SD-0.11

Week 48

LS Mean of Difference-0.6795% CI-3.088 - 1.739p0.583repeated measures model

Week 72

Effect size/pooled SD-0.08

Week 72

LS Mean of Difference-1.5995% CI-3.975 - 0.795p0.191repeated measures model

Week 72

Effect size/pooled SD-0.17

Week 72

LS Mean of Difference-1.1195% CI-3.541 - 1.329p0.372repeated measures model

Week 72

Effect size/pooled SD-0.12

Week 72

LS Mean of Difference-0.9995% CI-3.553 - 1.571p0.447repeated measures model

Week 96

Effect size/pooled SD-0.11

Week 96

LS Mean of Difference0.1995% CI-2.334 - 2.719p0.881repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

LS Mean of Difference-0.2595% CI-2.881 - 2.383p0.853repeated measures model

Week 96

Effect size/pooled SD-0.03

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in RBANS - Coding Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=109 Participants	-0.39	0.600
Change to Week 48n=98 Participants	-1.98	0.673
Change to Week 72n=95 Participants	-5.26	0.799
Change to Week 96n=77 Participants	-6.12	0.957
ABBV-8E12 300 mgChange to Week 24n=105 Participants	-1.29	0.611
Change to Week 48n=90 Participants	-1.17	0.694
Change to Week 72n=89 Participants	-2.80	0.819
Change to Week 96n=76 Participants	-6.95	0.970
ABBV-8E12 1000 mgChange to Week 24n=110 Participants	-1.40	0.595
Change to Week 48n=103 Participants	-2.38	0.660
Change to Week 72n=91 Participants	-4.58	0.799
Change to Week 96n=80 Participants	-6.70	0.940
ABBV-8E12 2000 mgChange to Week 24n=100 Participants	-1.40	0.623
Change to Week 48n=90 Participants	-3.14	0.698
Change to Week 72n=88 Participants	-4.53	0.828
Change to Week 96n=65 Participants	-7.30	1.016

LS Mean of Difference-0.9095% CI-2.567 - 0.762p0.287repeated measures model

Week 24

Effect size/pooled SD-0.13

Week 24

LS Mean of Difference-1.0195% CI-2.661 - 0.633p0.227repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference-1.0195% CI-2.698 - 0.681p0.241repeated measures model

Week 24

Effect size/pooled SD-0.16

Week 24

LS Mean of Difference0.8195% CI-1.073 - 2.696p0.397repeated measures model

Week 48

Effect size/pooled SD0.11

Week 48

LS Mean of Difference-0.4095% CI-2.239 - 1.443p0.671repeated measures model

Week 48

Effect size/pooled SD-0.05

Week 48

LS Mean of Difference-1.1695% CI-3.052 - 0.738p0.231repeated measures model

Week 48

Effect size/pooled SD-0.16

Week 48

LS Mean of Difference2.4795% CI0.230 - 4.701p0.031repeated measures model

Week 72

Effect size/pooled SD0.29

Week 72

LS Mean of Difference0.6895% CI-1.532 - 2.888p0.547repeated measures model

Week 72

Effect size/pooled SD0.07

Week 72

LS Mean of Difference0.7395% CI-1.521 - 2.984p0.524repeated measures model

Week 72

Effect size/pooled SD0.09

Week 72

LS Mean of Difference-0.8395% CI-3.499 - 1.836p0.540repeated measures model

Week 96

Effect size/pooled SD-0.08

Week 96

LS Mean of Difference-0.5895% CI-3.208 - 2.046p0.664repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

LS Mean of Difference-1.1995% CI-3.923 - 1.546p0.393repeated measures model

Week 96

Effect size/pooled SD-0.13

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Digit Span Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-0.48	0.185
Change to Week 48n=101 Participants	-0.75	0.207
Change to Week 72n=100 Participants	-0.94	0.194
Change to Week 96n=81 Participants	-1.07	0.229
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.50	0.189
Change to Week 48n=91 Participants	-0.65	0.217
Change to Week 72n=92 Participants	-0.89	0.201
Change to Week 96n=79 Participants	-0.81	0.232
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.78	0.184
Change to Week 48n=105 Participants	-0.41	0.204
Change to Week 72n=96 Participants	-1.13	0.196
Change to Week 96n=85 Participants	-0.83	0.224
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.64	0.193
Change to Week 48n=93 Participants	-0.65	0.216
Change to Week 72n=95 Participants	-0.79	0.199
Change to Week 96n=73 Participants	-0.90	0.239

LS Mean of Difference-0.0295% CI-0.534 - 0.498p0.946repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.3095% CI-0.813 - 0.206p0.242repeated measures model

Week 24

Effect size/pooled SD-0.14

Week 24

LS Mean of Difference-0.1695% CI-0.685 - 0.360p0.541repeated measures model

Week 24

Effect size/pooled SD-0.07

Week 24

LS Mean of Difference0.1195% CI-0.481 - 0.691p0.724repeated measures model

Week 48

Effect size/pooled SD0.04

Week 48

LS Mean of Difference0.3495% CI-0.226 - 0.913p0.236repeated measures model

Week 48

Effect size/pooled SD0.17

Week 48

LS Mean of Difference0.1195% CI-0.477 - 0.695p0.714repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference0.0595% CI-0.496 - 0.593p0.860repeated measures model

Week 72

Effect size/pooled SD0.02

Week 72

LS Mean of Difference-0.2095% CI-0.733 - 0.343p0.476repeated measures model

Week 72

Effect size/pooled SD-0.10

Week 72

LS Mean of Difference0.1595% CI-0.393 - 0.694p0.586repeated measures model

Week 72

Effect size/pooled SD0.08

Week 72

LS Mean of Difference0.2795% CI-0.371 - 0.903p0.412repeated measures model

Week 96

Effect size/pooled SD0.12

Week 96

LS Mean of Difference0.2495% CI-0.386 - 0.868p0.450repeated measures model

Week 96

Effect size/pooled SD0.11

Week 96

LS Mean of Difference0.1795% CI-0.481 - 0.816p0.612repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in RBANS - Figure Copy Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	0.29	0.287
Change to Week 48n=102 Participants	0.07	0.363
Change to Week 72n=100 Participants	-0.57	0.410
Change to Week 96n=81 Participants	-1.63	0.470
ABBV-8E12 300 mgChange to Week 24n=106 Participants	0.03	0.293
Change to Week 48n=91 Participants	-0.60	0.380
Change to Week 72n=92 Participants	-0.77	0.426
Change to Week 96n=79 Participants	-1.48	0.480
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.12	0.284
Change to Week 48n=105 Participants	-0.01	0.359
Change to Week 72n=97 Participants	-1.04	0.412
Change to Week 96n=84 Participants	-1.29	0.462
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.20	0.299
Change to Week 48n=93 Participants	-0.38	0.379
Change to Week 72n=93 Participants	-1.25	0.425
Change to Week 96n=74 Participants	-1.95	0.490

LS Mean of Difference-0.2695% CI-1.058 - 0.535p0.520repeated measures model

Week 24

Effect size/pooled SD-0.07

Week 24

LS Mean of Difference-0.4195% CI-1.201 - 0.374p0.303repeated measures model

Week 24

Effect size/pooled SD-0.13

Week 24

LS Mean of Difference-0.5095% CI-1.307 - 0.315p0.230repeated measures model

Week 24

Effect size/pooled SD-0.14

Week 24

LS Mean of Difference-0.6795% CI-1.698 - 0.356p0.200repeated measures model

Week 48

Effect size/pooled SD-0.16

Week 48

LS Mean of Difference-0.0895% CI-1.080 - 0.917p0.873repeated measures model

Week 48

Effect size/pooled SD-0.02

Week 48

LS Mean of Difference-0.4595% CI-1.482 - 0.576p0.388repeated measures model

Week 48

Effect size/pooled SD-0.12

Week 48

LS Mean of Difference-0.2095% CI-1.355 - 0.955p0.734repeated measures model

Week 72

Effect size/pooled SD-0.05

Week 72

LS Mean of Difference-0.4795% CI-1.608 - 0.668p0.417repeated measures model

Week 72

Effect size/pooled SD-0.11

Week 72

LS Mean of Difference-0.6895% CI-1.836 - 0.482p0.252repeated measures model

Week 72

Effect size/pooled SD-0.16

Week 72

LS Mean of Difference0.1595% CI-1.170 - 1.462p0.827repeated measures model

Week 96

Effect size/pooled SD0.03

Week 96

LS Mean of Difference0.3395% CI-0.962 - 1.624p0.615repeated measures model

Week 96

Effect size/pooled SD0.07

Week 96

LS Mean of Difference-0.3295% CI-1.653 - 1.014p0.637repeated measures model

Week 96

Effect size/pooled SD-0.07

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Figure Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=110 Participants	-0.23	0.259
Change to Week 48n=101 Participants	-0.97	0.276
Change to Week 72n=99 Participants	-1.21	0.262
Change to Week 96n=79 Participants	-1.16	0.299
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.65	0.264
Change to Week 48n=91 Participants	-0.70	0.288
Change to Week 72n=90 Participants	-1.16	0.272
Change to Week 96n=77 Participants	-1.43	0.305
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	0.06	0.256
Change to Week 48n=105 Participants	-0.22	0.272
Change to Week 72n=97 Participants	-0.68	0.263
Change to Week 96n=84 Participants	-0.86	0.293
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.60	0.268
Change to Week 48n=92 Participants	-1.18	0.288
Change to Week 72n=92 Participants	-1.45	0.272
Change to Week 96n=73 Participants	-1.49	0.310

LS Mean of Difference-0.4195% CI-1.135 - 0.308p0.261repeated measures model

Week 24

Effect size/pooled SD-0.13

Week 24

LS Mean of Difference0.2995% CI-0.420 - 1.001p0.423repeated measures model

Week 24

Effect size/pooled SD0.09

Week 24

LS Mean of Difference-0.3795% CI-1.097 - 0.361p0.322repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference0.2795% CI-0.511 - 1.049p0.498repeated measures model

Week 48

Effect size/pooled SD0.08

Week 48

LS Mean of Difference0.7595% CI-0.006 - 1.510p0.052repeated measures model

Week 48

Effect size/pooled SD0.23

Week 48

LS Mean of Difference-0.2195% CI-0.993 - 0.572p0.597repeated measures model

Week 48

Effect size/pooled SD-0.08

Week 48

LS Mean of Difference0.0595% CI-0.689 - 0.788p0.896repeated measures model

Week 72

Effect size/pooled SD0.01

Week 72

LS Mean of Difference0.5395% CI-0.192 - 1.258p0.149repeated measures model

Week 72

Effect size/pooled SD0.18

Week 72

LS Mean of Difference-0.2495% CI-0.980 - 0.499p0.522repeated measures model

Week 72

Effect size/pooled SD-0.09

Week 72

LS Mean of Difference-0.2795% CI-1.103 - 0.567p0.528repeated measures model

Week 96

Effect size/pooled SD-0.07

Week 96

LS Mean of Difference0.3095% CI-0.519 - 1.116p0.474repeated measures model

Week 96

Effect size/pooled SD0.09

Week 96

LS Mean of Difference-0.3395% CI-1.176 - 0.513p0.441repeated measures model

Week 96

Effect size/pooled SD-0.11

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - List Recognition Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	0.09	0.233
Change to Week 48n=101 Participants	0.31	0.231
Change to Week 72n=100 Participants	0.13	0.253
Change to Week 96n=80 Participants	-1.11	0.279
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.64	0.238
Change to Week 48n=91 Participants	0.29	0.242
Change to Week 72n=92 Participants	-0.55	0.262
Change to Week 96n=79 Participants	-1.42	0.281
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.38	0.232
Change to Week 48n=105 Participants	0.41	0.227
Change to Week 72n=97 Participants	-0.48	0.256
Change to Week 96n=85 Participants	-0.90	0.271
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.79	0.242
Change to Week 48n=93 Participants	-0.23	0.239
Change to Week 72n=94 Participants	-0.43	0.260
Change to Week 96n=74 Participants	-1.04	0.289

LS Mean of Difference-0.7395% CI-1.383 - -0.082p0.027repeated measures model

Week 24

Effect size/pooled SD-0.26

Week 24

LS Mean of Difference-0.4895% CI-1.123 - 0.167p0.146repeated measures model

Week 24

Effect size/pooled SD-0.16

Week 24

LS Mean of Difference-0.8895% CI-1.537 - -0.220p0.009repeated measures model

Week 24

Effect size/pooled SD-0.31

Week 24

LS Mean of Difference-0.0295% CI-0.674 - 0.634p0.952repeated measures model

Week 48

Effect size/pooled SD-0.01

Week 48

LS Mean of Difference0.1095% CI-0.540 - 0.734p0.764repeated measures model

Week 48

Effect size/pooled SD0.03

Week 48

LS Mean of Difference-0.5495% CI-1.191 - 0.109p0.103repeated measures model

Week 48

Effect size/pooled SD-0.19

Week 48

LS Mean of Difference-0.6895% CI-1.396 - 0.028p0.060repeated measures model

Week 72

Effect size/pooled SD-0.22

Week 72

LS Mean of Difference-0.6195% CI-1.316 - 0.098p0.091repeated measures model

Week 72

Effect size/pooled SD-0.20

Week 72

LS Mean of Difference-0.5695% CI-1.274 - 0.147p0.120repeated measures model

Week 72

Effect size/pooled SD-0.19

Week 72

LS Mean of Difference-0.3195% CI-1.090 - 0.464p0.429repeated measures model

Week 96

Effect size/pooled SD-0.10

Week 96

LS Mean of Difference0.2195% CI-0.559 - 0.970p0.597repeated measures model

Week 96

Effect size/pooled SD0.07

Week 96

LS Mean of Difference0.0795% CI-0.717 - 0.858p0.860repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - List Learning Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-0.57	0.350
Change to Week 48n=102 Participants	-1.27	0.397
Change to Week 72n=100 Participants	-3.18	0.413
Change to Week 96n=82 Participants	-3.57	0.484
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.67	0.359
Change to Week 48n=91 Participants	-0.36	0.416
Change to Week 72n=92 Participants	-3.32	0.428
Change to Week 96n=79 Participants	-2.93	0.496
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.98	0.348
Change to Week 48n=105 Participants	-1.89	0.392
Change to Week 72n=97 Participants	-3.02	0.415
Change to Week 96n=87 Participants	-3.23	0.474
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-1.14	0.364
Change to Week 48n=93 Participants	-1.17	0.413
Change to Week 72n=95 Participants	-3.11	0.424
Change to Week 96n=75 Participants	-3.07	0.503

LS Mean of Difference-0.0995% CI-1.069 - 0.885p0.854repeated measures model

Week 24

Effect size/pooled SD-0.02

Week 24

LS Mean of Difference-0.4095% CI-1.368 - 0.562p0.412repeated measures model

Week 24

Effect size/pooled SD-0.10

Week 24

LS Mean of Difference-0.5795% CI-1.554 - 0.424p0.262repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference0.9195% CI-0.209 - 2.036p0.110repeated measures model

Week 48

Effect size/pooled SD0.22

Week 48

LS Mean of Difference-0.6295% CI-1.713 - 0.469p0.263repeated measures model

Week 48

Effect size/pooled SD-0.15

Week 48

LS Mean of Difference0.1095% CI-1.026 - 1.217p0.868repeated measures model

Week 48

Effect size/pooled SD0.02

Week 48

LS Mean of Difference-0.1395% CI-1.298 - 1.029p0.820repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference0.1695% CI-0.984 - 1.308p0.781repeated measures model

Week 72

Effect size/pooled SD0.04

Week 72

LS Mean of Difference0.0895% CI-1.082 - 1.238p0.895repeated measures model

Week 72

Effect size/pooled SD0.02

Week 72

LS Mean of Difference0.6395% CI-0.724 - 1.991p0.359repeated measures model

Week 96

Effect size/pooled SD0.14

Week 96

LS Mean of Difference0.3495% CI-0.985 - 1.670p0.612repeated measures model

Week 96

Effect size/pooled SD0.07

Week 96

LS Mean of Difference0.5095% CI-0.872 - 1.867p0.475repeated measures model

Week 96

Effect size/pooled SD0.11

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Line Orientation Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	0.20	0.301
Change to Week 48n=101 Participants	-0.84	0.348
Change to Week 72n=100 Participants	-0.64	0.365
Change to Week 96n=77 Participants	-1.33	0.404
ABBV-8E12 300 mgChange to Week 24n=106 Participants	0.24	0.308
Change to Week 48n=91 Participants	0.05	0.363
Change to Week 72n=92 Participants	-0.07	0.378
Change to Week 96n=79 Participants	-1.01	0.405
ABBV-8E12 1000 mgChange to Week 24n=110 Participants	-0.05	0.301
Change to Week 48n=104 Participants	-0.53	0.344
Change to Week 72n=95 Participants	-0.60	0.369
Change to Week 96n=84 Participants	-0.99	0.392
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	0.03	0.313
Change to Week 48n=92 Participants	-0.47	0.363
Change to Week 72n=94 Participants	-0.60	0.377
Change to Week 96n=69 Participants	-1.88	0.424

LS Mean of Difference0.0495% CI-0.799 - 0.878p0.926repeated measures model

Week 24

Effect size/pooled SD0.01

Week 24

LS Mean of Difference-0.2595% CI-1.082 - 0.580p0.553repeated measures model

Week 24

Effect size/pooled SD-0.06

Week 24

LS Mean of Difference-0.1795% CI-1.021 - 0.677p0.690repeated measures model

Week 24

Effect size/pooled SD-0.04

Week 24

LS Mean of Difference0.9095% CI-0.085 - 1.879p0.073repeated measures model

Week 48

Effect size/pooled SD0.22

Week 48

LS Mean of Difference0.3295% CI-0.641 - 1.273p0.517repeated measures model

Week 48

Effect size/pooled SD0.07

Week 48

LS Mean of Difference0.3895% CI-0.609 - 1.360p0.454repeated measures model

Week 48

Effect size/pooled SD0.08

Week 48

LS Mean of Difference0.5795% CI-0.456 - 1.596p0.276repeated measures model

Week 72

Effect size/pooled SD0.14

Week 72

LS Mean of Difference0.0495% CI-0.973 - 1.058p0.935repeated measures model

Week 72

Effect size/pooled SD0.01

Week 72

LS Mean of Difference0.0495% CI-0.990 - 1.066p0.942repeated measures model

Week 72

Effect size/pooled SD0.01

Week 72

LS Mean of Difference0.3295% CI-0.802 - 1.436p0.578repeated measures model

Week 96

Effect size/pooled SD0.09

Week 96

LS Mean of Difference0.56095% CI-0.762 - 1.441p0.545repeated measures model

Week 96

Effect size/pooled SD0.09

Week 96

LS Mean of Difference-0.5595% CI-1.697 - 0.597p0.346repeated measures model

Week 96

Effect size/pooled SD-0.14

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - List Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	0.04	0.102
Change to Week 48n=101 Participants	0.07	0.120
Change to Week 72n=100 Participants	0.01	0.081
Change to Week 96n=80 Participants	-0.14	0.095
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.15	0.105
Change to Week 48n=91 Participants	0.05	0.125
Change to Week 72n=92 Participants	-0.29	0.084
Change to Week 96n=79 Participants	-0.39	0.096
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.01	0.102
Change to Week 48n=105 Participants	0.10	0.118
Change to Week 72n=97 Participants	-0.24	0.082
Change to Week 96n=86 Participants	-0.35	0.092
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.08	0.106
Change to Week 48n=93 Participants	-0.10	0.124
Change to Week 72n=95 Participants	-0.27	0.083
Change to Week 96n=75 Participants	-0.31	0.098

LS Mean of Difference-0.1995% CI-0.473 - 0.100p0.202repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference-0.0495% CI-0.327 - 0.239p0.760repeated measures model

Week 24

Effect size/pooled SD-0.04

Week 24

LS Mean of Difference-0.1295% CI-0.409 - 0.170p0.419repeated measures model

Week 24

Effect size/pooled SD-0.12

Week 24

LS Mean of Difference-0.0295% CI-0.363 - 0.317p0.893repeated measures model

Week 48

Effect size/pooled SD-0.02

LS Mean of Difference0.0295% CI-0.306 - 0.354p0.886repeated measures model

Week 48

Effect size/pooled SD0.02

Week 48

LS Mean of Difference-0.1895% CI-0.515 - 0.162p0.306repeated measures model

Week 48

Effect size/pooled SD-0.16

Week 48

LS Mean of Difference-0.3195% CI-0.535 - -0.079p0.008repeated measures model

Week 72

Effect size/pooled SD-0.26

Week 72

LS Mean of Difference-0.2595% CI-0.474 - -0.023p0.031repeated measures model

Week 72

Effect size/pooled SD-0.21

Week 72

LS Mean of Difference-0.2995% CI-0.514 - -0.059p0.014repeated measures model

Week 72

Effect size/pooled SD-0.25

LS Mean of Difference-0.2595% CI-0.514 - 0.016p0.065repeated measures model

Week 96

Effect size/pooled SD-0.21

Week 96

LS Mean of Difference-0.2195% CI-0.465 - 0.055p0.121repeated measures model

Week 96

Effect size/pooled SD1.05

Week 96

LS Mean of Difference-0.1795% CI-0.438 - 0.097p0.210repeated measures model

Week 96

Effect size/pooled SD-0.17

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Picture Naming Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-0.68	0.132
Change to Week 48n=101 Participants	-0.21	0.112
Change to Week 72n=100 Participants	-0.91	0.162
Change to Week 96n=81 Participants	-0.68	0.152
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-0.87	0.136
Change to Week 48n=91 Participants	-0.10	0.117
Change to Week 72n=92 Participants	-0.81	0.168
Change to Week 96n=79 Participants	-0.94	0.155
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.85	0.132
Change to Week 48n=105 Participants	-0.09	0.110
Change to Week 72n=97 Participants	-0.63	0.163
Change to Week 96n=87 Participants	-0.65	0.148
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.86	0.138
Change to Week 48n=93 Participants	-0.14	0.116
Change to Week 72n=95 Participants	-0.75	0.167
Change to Week 96n=75 Participants	-0.77	0.157

LS Mean of Difference-0.1995% CI-0.564 - 0.176p0.303repeated measures model

Week 24

Effect size/pooled SD-0.14

Week 24

LS Mean of Difference-0.1795% CI-0.536 - 0.194p0.358repeated measures model

Week 24

Effect size/pooled SD-0.13

Week 24

LS Mean of Difference-0.1895% CI-0.553 - 0.195p0.347repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference0.1195% CI-0.205 - 0.423p0.494repeated measures model

Week 48

Effect size/pooled SD0.09

Week 48

LS Mean of Difference0.1295% CI-0.189 - 0.423p0.454repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference0.0795% CI-0.240 - 0.388p0.644repeated measures model

Week 48

Effect size/pooled SD0.07

Week 48

LS Mean of Difference0.0995% CI-0.363 - 0.551p0.685repeated measures model

Week 72

Effect size/pooled SD0.06

Week 72

LS Mean of Difference0.2895% CI-0.168 - 0.730p0.219repeated measures model

Week 72

Effect size/pooled SD0.18

Week 72

LS Mean of Difference0.1595% CI-0.302 - 0.610p0.507repeated measures model

Week 72

Effect size/pooled SD0.10

Week 72

LS Mean of Difference-0.2695% CI-0.683 - 0.167p0.233repeated measures model

Week 96

Effect size/pooled SD-0.20

Week 96

LS Mean of Difference0.0395% CI-0.383 - 0.446p0.881repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

LS Mean of Difference-0.0995% CI-0.520 - 0.335p0.671repeated measures model

Week 96

Effect size/pooled SD-0.08

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Semantic Fluency Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-1.47	0.289
Change to Week 48n=101 Participants	-1.03	0.441
Change to Week 72n=100 Participants	-4.07	0.462
Change to Week 96n=81 Participants	-2.29	0.408
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-1.90	0.296
Change to Week 48n=91 Participants	-1.00	0.462
Change to Week 72n=92 Participants	-4.50	0.480
Change to Week 96n=79 Participants	-2.87	0.415
ABBV-8E12 1000 mgChange to Week 24n=111 Participants	-1.48	0.288
Change to Week 48n=105 Participants	-0.90	0.434
Change to Week 72n=97 Participants	-4.38	0.465
Change to Week 96n=87 Participants	-2.83	0.397
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-1.65	0.300
Change to Week 48n=92 Participants	-0.79	0.460
Change to Week 72n=95 Participants	-4.26	0.475
Change to Week 96n=74 Participants	-2.78	0.425

LS Mean of Difference-0.4395% CI-1.232 - 0.377p0.297repeated measures model

Week 24

Effect size/pooled SD-0.12

Week 24

LS Mean of Difference-0.0195% CI-0.808 - 0.786p0.979repeated measures model

Week 24

Effect size/pooled SD-0.00

Week 24

LS Mean of Difference-0.1895% CI-0.996 - 0.634p0.663repeated measures model

Week 24

Effect size/pooled SD-0.05

Week 24

LS Mean of Difference0.0395% CI-1.220 - 1.282p0.961repeated measures model

Week 48

Effect size/pooled SD0.01

Week 48

LS Mean of Difference0.1395% CI-1.083 - 1.344p0.833repeated measures model

Week 48

Effect size/pooled SD0.03

Week 48

LS Mean of Difference0.2395% CI-1.017 - 1.484p0.714repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference-0.4395% CI-1.733 - 0.876p0.518repeated measures model

Week 72

Effect size/pooled SD-0.08

Week 72

LS Mean of Difference-0.3195% CI-1.598 - 0.973p0.633repeated measures model

Week 72

Effect size/pooled SD-0.06

Week 72

LS Mean of Difference-0.1995% CI-1.488 - 1.112p0.776repeated measures model

Week 72

Effect size/pooled SD-0.04

Week 72

LS Mean of Difference-0.5895% CI-1.723 - 0.558p0.316repeated measures model

Week 96

Effect size/pooled SD-0.15

Week 96

LS Mean of Difference-0.5595% CI-1.660 - 0.569p0.336repeated measures model

Week 96

Effect size/pooled SD-0.14

Week 96

LS Mean of Difference-0.4995% CI-1.647 - 0.663p0.403repeated measures model

Week 96

Effect size/pooled SD-0.13

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Story Memory Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-3.06	0.282
Change to Week 48n=102 Participants	-1.62	0.324
Change to Week 72n=100 Participants	-2.15	0.381
Change to Week 96n=82 Participants	-3.31	0.380
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-3.13	0.289
Change to Week 48n=91 Participants	-1.07	0.341
Change to Week 72n=92 Participants	-2.00	0.396
Change to Week 96n=79 Participants	-2.67	0.388
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-2.93	0.280
Change to Week 48n=105 Participants	-0.70	0.320
Change to Week 72n=97 Participants	-1.84	0.384
Change to Week 96n=86 Participants	-2.46	0.372
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-2.99	0.293
Change to Week 48n=93 Participants	-1.01	0.338
Change to Week 72n=94 Participants	-2.10	0.393
Change to Week 96n=74 Participants	-2.45	0.397

LS Mean of Difference-0.0795% CI-0.856 - 0.716p0.861repeated measures model

Week 24

Effect size/pooled SD-0.02

Week 24

LS Mean of Difference0.1395% CI-0.648 - 0.905p0.746repeated measures model

Week 24

Effect size/pooled SD0.04

Week 24

LS Mean of Difference0.0795% CI-0.724 - 0.868p0.859repeated measures model

Week 24

Effect size/pooled SD0.02

Week 24

LS Mean of Difference0.5595% CI-0.369 - 1.469p0.240repeated measures model

Week 48

Effect size/pooled SD0.16

Week 48

LS Mean of Difference0.9195% CI0.023 - 1.087p0.044repeated measures model

Week 48

Effect size/pooled SD0.26

Week 48

LS Mean of Difference0.6195% CI-0.312 - 1.524p0.195repeated measures model

Week 48

Effect size/pooled SD0.17

Week 48

LS Mean of Difference0.1595% CI-0.921 - 1.229p0.778repeated measures model

Week 72

Effect size/pooled SD0.04

Week 72

LS Mean of Difference0.3295% CI-0.743 - 1.376p0.558repeated measures model

Week 72

Effect size/pooled SD0.08

Week 72

LS Mean of Difference0.0595% CI-1.025 - 1.124p0.928repeated measures model

Week 72

Effect size/pooled SD0.01

Week 72

LS Mean of Difference0.6495% CI-0.425 - 1.704p0.238repeated measures model

Week 96

Effect size/pooled SD0.18

Week 96

LS Mean of Difference0.8695% CI-0.186 - 1.898p0.107repeated measures model

Week 96

Effect size/pooled SD0.25

Week 96

LS Mean of Difference0.8695% CI-0.214 - 1.942p0.116repeated measures model

Week 96

Effect size/pooled SD0.23

Week 96

Secondary/registry result

Change From Baseline Over Time in RBANS - Story Recall Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 24n=111 Participants	-0.93	0.132
Change to Week 48n=101 Participants	-0.70	0.178
Change to Week 72n=100 Participants	-0.90	0.179
Change to Week 96n=81 Participants	-1.28	0.197
ABBV-8E12 300 mgChange to Week 24n=106 Participants	-1.01	0.135
Change to Week 48n=91 Participants	-0.95	0.186
Change to Week 72n=92 Participants	-1.12	0.186
Change to Week 96n=79 Participants	-1.10	0.201
ABBV-8E12 1000 mgChange to Week 24n=112 Participants	-0.93	0.131
Change to Week 48n=105 Participants	-0.60	0.175
Change to Week 72n=97 Participants	-0.90	0.181
Change to Week 96n=86 Participants	-0.96	0.192
ABBV-8E12 2000 mgChange to Week 24n=102 Participants	-0.95	0.137
Change to Week 48n=93 Participants	-0.69	0.137
Change to Week 72n=94 Participants	-1.38	0.185
Change to Week 96n=74 Participants	-1.35	0.205

LS Mean of Difference-0.0895% CI-0.442 - 0.290p0.683repeated measures model

Week 24

Effect size/pooled SD-0.04

Week 24

LS Mean of Difference0.0195% CI-0.356 - 0.368p0.973repeated measures model

Week 24

Effect size/pooled SD0.00

Week 24

LS Mean of Difference-0.0295% CI-0.389 - 0.352p0.921repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.2595% CI-0.751 - 0.257p0.335repeated measures model

Week 48

Effect size/pooled SD-0.11

Week 48

LS Mean of Difference0.1195% CI-0.383 - 0.596p0.670repeated measures model

Week 48

Effect size/pooled SD0.05

Week 48

LS Mean of Difference0.0295% CI-0.486 - 0.519p0.950repeated measures model

Week 48

Effect size/pooled SD0.01

Week 48

LS Mean of Difference-0.2295% CI-0.729 - 0.281p0.383repeated measures model

Week 72

Effect size/pooled SD-0.10

Week 24

LS Mean of Difference-0.0095% CI-0.504 - 0.494p0.985repeated measures model

Week 72

Effect size/pooled SD-0.00

Week 72

LS Mean of Difference-0.4895% CI-0.982 - 0.027p0.064repeated measures model

Week 72

Effect size/pooled SD-0.20

Week 72

LS Mean of Difference0.1895% CI-0.374 - 0.729p0.527repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

LS Mean of Difference0.3195% CI-0.226 - 0.854p0.254repeated measures model

Week 96

Effect size/pooled SD0.14

Week 96

LS Mean of Difference-0.0795% CI-0.628 - 0.488p0.805repeated measures model

Week 96

Effect size/pooled SD-0.03

Week 96

Secondary/registry result

Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=111 Participants	-0.60	0.255
Change at Week 48n=102 Participants	-1.78	0.294
Change at Week 72n=100 Participants	-2.83	0.376
Change at Week 96n=83 Participants	-3.95	0.478
ABBV-8E12 300 mgChange at Week 24n=106 Participants	-0.83	0.260
Change at Week 48n=92 Participants	-1.81	0.305
Change at Week 72n=91 Participants	-2.92	0.388
Change at Week 96n=81 Participants	-4.06	0.488
ABBV-8E12 1000 mgChange at Week 24n=113 Participants	-0.48	0.252
Change at Week 48n=105 Participants	-1.60	0.290
Change at Week 72n=97 Participants	-2.43	0.375
Change at Week 96n=88 Participants	-3.70	0.469
ABBV-8E12 2000 mgChange at Week 24n=103 Participants	-1.56	0.263
Change at Week 48n=92 Participants	-2.17	0.305
Change at Week 72n=94 Participants	-3.34	0.386
Change at Week 96n=76 Participants	-4.71	0.494

LS Mean of Difference-0.2295% CI-0.935 - 0.485p0.534repeated measures model

Week 24

Effect size/pooled SD-0.08

Week 24

LS Mean of Difference0.1295% CI-0.580 - 0.821p0.735repeated measures model

Week 24

Effect size/pooled SD0.04

Week 24

LS Mean of Difference-0.9695% CI-1.673 - -0.240p0.009repeated measures model

Week 24

Effect size/pooled SD-0.35

Week 24

LS Mean of Difference-0.0295% CI-0.854 - 0.806p0.954repeated measures model

Week 48

Effect size/pooled SD-0.01

Week 48

LS Mean of Difference0.1995% CI-0.622 - 0.997p0.649repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.3995% CI-1.220 - 0.443p0.358repeated measures model

Week 48

Effect size/pooled SD-0.13

Week 48

LS Mean of Difference-0.1095% CI-1.155 - 0.963p0.859repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference0.4095% CI-0.644 - 1.437p0.455repeated measures model

Week 72

Effect size/pooled SD0.11

Week 72

LS Mean of Difference-0.5295% CI-1.578 - 0.539p0.335repeated measures model

Week 72

Effect size/pooled SD-0.15

Week 72

LS Mean of Difference-0.1195% CI-1.447 - 1.233p0.875repeated measures model

Week 96

Effect size/pooled SD-0.02

Week 96

LS Mean of Difference0.2595% CI-1.068 - 1.561p0.712repeated measures model

Week 96

Effect size/pooled SD0.05

Week 96

LS Mean of Difference-0.7695% CI-2.112 - 0.590p0.269repeated measures model

Week 96

Effect size/pooled SD-0.16

Week 96

Secondary/registry result

Change From Baseline Over Time in Alzheimer's Disease Composite Score (ADCOMS) Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=100 Participants	0.05	0.013
Change at Week 48n=89 Participants	0.13	0.018
Change at Week 72n=85 Participants	0.22	0.023
Change at Week 96n=72 Participants	0.29	0.029
ABBV-8E12 300 mgChange at Week 24n=98 Participants	0.08	0.013
Change at Week 48n=82 Participants	0.15	0.018
Change at Week 72n=79 Participants	0.22	0.024
Change at Week 96n=74 Participants	0.29	0.030
ABBV-8E12 1000 mgChange at Week 24n=107 Participants	0.05	0.013
Change at Week 48n=99 Participants	0.13	0.017
Change at Week 72n=85 Participants	0.22	0.023
Change at Week 96n=79 Participants	0.28	0.029
ABBV-8E12 2000 mgChange at Week 24n=95 Participants	0.08	0.014
Change at Week 48n=83 Participants	0.13	0.018
Change at Week 72n=84 Participants	0.22	0.024
Change at Week 96n=65 Participants	0.35	0.031

LS Mean of Difference0.0395% CI-0.010 - 0.064p0.147repeated measures model

Week 24

Effect size/pooled SD-0.20

Week 24

LS Mean of Difference-0.0095% CI-0.041 - 0.031p0.795repeated measures model

Week 24

Effect size/pooled SD0.12

Week 24

LS Mean of Difference0.0395% CI-0.006 - 0.069p0.095repeated measures model

Week 24

Effect size/pooled SD-0.24

Week 24

LS Mean of Difference0.0295% CI-0.028 - 0.072p0.390repeated measures model

Week 48

Effect size/pooled SD-0.12

Week 48

LS Mean of Difference-0.0095% CI-0.052 - 0.045p0.898repeated measures model

Week 48

Effect size/pooled SD0.02

Week 48

LS Mean of Difference0.0195% CI-0.044 - 0.057p0.800repeated measures model

Week 48

Effect size/pooled SD-0.04

Week 48

LS Mean of Difference-0.0095% CI-0.066 - 0.064p0.977repeated measures model

Week 72

Effect size/pooled SD0.00

Week 72

LS Mean of Difference0.0095% CI-0.063 - 0.064p0.990repeated measures model

Week 72

Effect size/pooled SD-0.00

Week 72

LS Mean of Difference0.0095% CI-0.063 - 0.067p0.944repeated measures model

Week 72

Effect size/pooled SD-0.01

Week 72

LS Mean of Difference0.0095% CI-0.079 - 0.085p0.942repeated measures model

Week 96

Effect size/pooled SD-0.01

Week 96

LS Mean of Difference-0.0195% CI-0.087 - 0.074p0.876repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

LS Mean of Difference0.0695% CI-0.024 - 0.143p0.163repeated measures model

Week 96

Effect size/pooled SD-0.21

Week 96

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

Time frame:Baseline, Week 48, Week 96

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Functional Activities Questionnaire (FAQ) Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=112 Participants	1.63	0.422
Change at Week 48n=105 Participants	3.37	0.480
Change at Week 72n=100 Participants	5.62	0.571
Change at Week 96n=86 Participants	6.14	0.650
ABBV-8E12 300 mgChange at Week 24n=105 Participants	1.84	0.435
Change at Week 48n=96 Participants	3.53	0.498
Change at Week 72n=95 Participants	5.09	0.588
Change at Week 96n=85 Participants	7.11	0.663
ABBV-8E12 1000 mgChange at Week 24n=111 Participants	1.19	0.423
Change at Week 48n=106 Participants	2.83	0.477
Change at Week 72n=101 Participants	4.57	0.568
Change at Week 96n=92 Participants	5.80	0.638
ABBV-8E12 2000 mgChange at Week 24n=103 Participants	2.06	0.439
Change at Week 48n=98 Participants	3.58	0.496
Change at Week 72n=96 Participants	6.31	0.586
Change at Week 96n=82 Participants	7.94	0.667

LS Mean of Difference0.2195% CI-0.965 - 1.395p0.720repeated measures model

Week 24

Effect size/pooled SD-0.05

Week 24

LS Mean of Difference-0.4495% CI-1.607 - 0.722p0.455repeated measures model

Week 24

Effect size/pooled SD0.10

Week 24

LS Mean of Difference0.4395% CI-0.755 - 1.625p0.473repeated measures model

Week 24

Effect size/pooled SD-0.10

Week 24

LS Mean of Difference0.1695% CI-1.187 - 1.512p0.813repeated measures model

Week 48

Effect size/pooled SD-0.03

Week 48

LS Mean of Difference-0.5495% CI-1.863 - 0.780p0.421repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference0.2195% CI-1.139 - 1.564p0.758repeated measures model

Week 48

Effect size/pooled SD-0.04

Week 48

LS Mean of Difference-0.5495% CI-2.140 - 1.066p0.511repeated measures model

Week 72

Effect size/pooled SD0.09

Week 72

LS Mean of Difference-1.0595% CI-2.623 - 0.527p0.192repeated measures model

Week 72

Effect size/pooled SD0.17

Week 72

LS Mean of Difference0.6995% CI-0.914 - 2.294p0.398repeated measures model

Week 72

Effect size/pooled SD-0.12

Week 72

LS Mean of Difference0.9795% CI-0.851 - 2.784p0.296repeated measures model

Week 96

Effect size/pooled SD-0.14

Week 96

LS Mean of Difference-0.3495% CI-2.126 - 1.442p0.706repeated measures model

Week 96

Effect size/pooled SD0.05

Week 96

LS Mean of Difference1.7995% CI-0.036 - 3.617p0.055repeated measures model

Week 96

Effect size/pooled SD-0.28

Week 96

Secondary/registry result

Change From Baseline Over Time in 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients With Mild Cognitive Impairment (ADCS-MCI-ADL-24) Total Score

Time frame:Baseline, Week 48, Week 96

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 48n=103 Participants	-3.72	0.723
Change to Week 96n=83 Participants	-9.21	1.134
ABBV-8E12 300 mgChange to Week 48n=98 Participants	-4.51	0.738
Change to Week 96n=85 Participants	-10.25	1.135
ABBV-8E12 1000 mgChange to Week 48n=105 Participants	-2.91	0.712
Change to Week 96n=87 Participants	-9.16	1.112
ABBV-8E12 2000 mgChange to Week 48n=98 Participants	-3.65	0.740
Change to Week 96n=79 Participants	-10.60	1.163

LS Mean of Difference-0.7995% CI-2.798 - 1.214p0.438repeated measures model

Week 48

Effect size/pooled SD-0.10

Week 48

LS Mean of Difference0.8195% CI-1.164 - 2.788p0.419repeated measures model

Week 48

Effect size/pooled SD0.10

Week 48

LS Mean of Difference0.0795% CI-1.959 - 2.092p0.948repeated measures model

Week 48

Effect size/pooled SD0.01

Week 48

LS Mean of Difference-1.0495% CI-4.180 - 2.101p0.516repeated measures model

Week 96

Effect size/pooled SD-0.10

Week 96

LS Mean of Difference0.0695% CI-3.055 - 3.168p0.971repeated measures model

Week 96

Effect size/pooled SD0.01

Week 96

LS Mean of Difference-1.3995% CI-4.577 - 1.800p0.392repeated measures model

Week 96

Effect size/pooled SD-0.13

Week 96

Behavior / neuropsychiatric

8 endpoints

Secondary/protocol endpoint

Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI) General Condition Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 48n=99 Participants	4.91	0.078
Change at Week 96n=83 Participants	5.29	0.087
ABBV-8E12 300 mgChange at Week 48n=95 Participants	4.86	0.080
Change at Week 96n=83 Participants	5.28	0.087
ABBV-8E12 1000 mgChange at Week 48n=104 Participants	4.80	0.076
Change at Week 96n=89 Participants	5.22	0.083
ABBV-8E12 2000 mgChange at Week 48n=95 Participants	4.87	0.079
Change at Week 96n=80 Participants	5.34	0.088

LS Mean of Difference-0.0595% CI-0.266 - 0.166p0.651repeated measures model

Week 48

Effect size/pooled SD0.06

Week 48

LS Mean of Difference-0.1195% CI-0.318 - 0.104p0.320repeated measures model

Week 48

Effect size/pooled SD0.13

Week 48

LS Mean of Difference-0.0395% CI-0.250 - 0.182p0.757repeated measures model

Week 48

Effect size/pooled SD0.04

Week 48

LS Mean of Difference-0.0095% CI-0.241 - 0.236p0.984repeated measures model

Week 96

Effect size/pooled SD0.00

Week 96

LS Mean of Difference-0.0695% CI-0.296 - 0.170p0.595repeated measures model

Week 96

Effect size/pooled SD0.07

Week 96

LS Mean of Difference0.0595% CI-0.187 - 0.291p0.670repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

Secondary/registry result

Change From Baseline Over Time in ADCS-CGIC-MCI Behavior Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 48n=99 Participants	4.30	0.061
Change at Week 96n=83 Participants	4.61	0.079
ABBV-8E12 300 mgChange at Week 48n=95 Participants	4.31	0.062
Change at Week 96n=83 Participants	4.49	0.078
ABBV-8E12 1000 mgChange at Week 48n=104 Participants	4.28	0.059
Change at Week 96n=89 Participants	4.57	0.076
ABBV-8E12 2000 mgChange at Week 48n=95 Participants	4.33	0.062
Change at Week 96n=80 Participants	4.55	0.080

LS Mean of Difference0.0195% CI-0.159 - 0.180p0.903repeated measures model

Week 48

Effect size/pooled SD-0.02

Week 48

LS Mean of Difference-0.0295% CI-0.185 - 0.145p0.811repeated measures model

Week 48

Effect size/pooled SD0.03

Week 48

LS Mean of Difference0.0295% CI-0.145 - 0.194p0.775repeated measures model

Week 48

Effect size/pooled SD-0.04

Week 48

LS Mean of Difference-0.1295% CI-0.337 - 0.096p0.273repeated measures model

Week 96

Effect size/pooled SD0.17

Week 96

LS Mean of Difference-0.0495% CI-0.248 - 0.176p0.740repeated measures model

Week 96

Effect size/pooled SD0.05

Week 96

LS Mean of Difference-0.0695% CI-0.282 - 0.155p0.567repeated measures model

Week 96

Effect size/pooled SD0.08

Week 96

Secondary/registry result

Change From Baseline Over Time in ADCS-CGIC-MCI Functional Abilities Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 48n=99 Participants	4.59	0.071
Change at Week 96n=83 Participants	4.97	0.088
ABBV-8E12 300 mgChange at Week 48n=95 Participants	4.58	0.072
Change at Week 96n=83 Participants	4.95	0.088
ABBV-8E12 1000 mgChange at Week 48n=104 Participants	4.46	0.068
Change at Week 96n=89 Participants	4.98	0.085
ABBV-8E12 2000 mgChange at Week 48n=95 Participants	4.59	0.072
Change at Week 96n=80 Participants	5.03	0.090

LS Mean of Difference-0.0195% CI-0.204 - 0.187p0.931repeated measures model

Week 48

Effect size/pooled SD0.01

Week 48

LS Mean of Difference-0.1395% CI-0.320 - 0.063p0.187repeated measures model

Week 48

Effect size/pooled SD0.16

Week 48

LS Mean of Difference0.0095% CI-0.191 - 0.201p0.961repeated measures model

Week 48

Effect size/pooled SD-0.01

Week 96

LS Mean of Difference-0.0295% CI-0.260 - 0.227p0.894repeated measures model

Week 96

Effect size/pooled SD0.02

Week 96

LS Mean of Difference0.0195% CI-0.226 - 0.251p0.917repeated measures model

Week 96

Effect size/pooled SD-0.01

Week 96

LS Mean of Difference0.0695% CI-0.186 - 0.303p0.639repeated measures model

Week 96

Effect size/pooled SD-0.06

Week 96

Secondary/protocol endpoint

Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline Over Time in Neuropsychiatry Inventory (NPI) Total Score

Time frame:Baseline, Week 24, Week 48, Week 72, Week 96

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange at Week 24n=111 Participants	0.93	0.551
Change at Week 36n=104 Participants	-0.03	0.487
Change at Week 72n=102 Participants	1.34	0.742
Change at Week 96n=86 Participants	2.38	0.784
ABBV-8E12 300 mgChange at Week 24n=105 Participants	0.96	0.567
Change at Week 36n=96 Participants	0.84	0.505
Change at Week 72n=95 Participants	1.52	0.767
Change at Week 96n=86 Participants	2.03	0.794
ABBV-8E12 1000 mgChange at Week 24n=111 Participants	0.80	0.551
Change at Week 36n=107 Participants	0.99	0.481
Change at Week 72n=100 Participants	1.80	0.745
Change at Week 96n=91 Participants	2.53	0.769
ABBV-8E12 2000 mgChange at Week 24n=101 Participants	1.92	0.576
Change at Week 36n=98 Participants	1.32	0.502
Change at Week 72n=96 Participants	3.25	0.765
Change at Week 96n=82 Participants	2.94	0.804

LS Mean of Difference0.0395% CI-1.509 - 1.577p0.966repeated measures model

Week 24

Effect size/pooled SD-0.01

Week 24

LS Mean of Difference-0.1295% CI-1.646 - 1.400p0.874repeated measures model

Week 24

Effect size/pooled SD0.02

Week 24

LS Mean of Difference0.9995% CI-0.572 - 2.551p0.213repeated measures model

Week 24

Effect size/pooled SD-0.15

Week 24

LS Mean of Difference0.8895% CI-0.490 - 2.242p0.208repeated measures model

Week 48

Effect size/pooled SD-0.17

Week 48

LS Mean of Difference1.0395% CI-0.307 - 2.365p0.131repeated measures model

Week 48

Effect size/pooled SD-0.18

Week 48

LS Mean of Difference1.3595% CI-0.014 - 2.719p0.052repeated measures model

Week 48

Effect size/pooled SD-0.24

Week 48

LS Mean of Difference0.1895% CI-1.908 - 2.268p0.866repeated measures model

Week 72

Effect size/pooled SD-0.03

Week 72

LS Mean of Difference0.4695% CI-1.599 - 2.523p0.660repeated measures model

Week 72

Effect size/pooled SD-0.07

Week 72

LS Mean of Difference1.9195% CI-0.184 - 3.995p0.074repeated measures model

Week 72

Effect size/pooled SD-0.22

Week 72

LS Mean of Difference-0.3695% CI-2.545 - 1.828p0.747repeated measures model

Week 96

Effect size/pooled SD0.04

Week 96

LS Mean of Difference0.1595% CI-2.004 - 2.304p0.891repeated measures model

Week 96

Effect size/pooled SD-0.02

Week 96

LS Mean of Difference0.5595% CI-1.650 - 2.759p0.621repeated measures model

Week 96

Effect size/pooled SD-0.07

Week 96

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)

event count, event

Primary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to last dose of study drug plus 20 weeks (up to Week 112)

event count, event

Posted result

Group	Value (number), participants	Reported bounds
PlaceboAny TEAEn=116 Participants	108	-
Severe TEAEn=116 Participants	12	-
TEAE With a Reasonable Possibility to Study Drugn=116 Participants	28	-
SAEn=116 Participants	26	-
TEAE Leading to Discontinuation of Study Drugn=116 Participants	4	-
Fatal TEAEn=116 Participants	1	-
All Deathsn=116 Participants	1	-
ABBV-8E12 300 mgAny TEAEn=108 Participants	94	-
Severe TEAEn=108 Participants	13	-
TEAE With a Reasonable Possibility to Study Drugn=108 Participants	32	-
SAEn=108 Participants	19	-
TEAE Leading to Discontinuation of Study Drugn=108 Participants	6	-
Fatal TEAEn=108 Participants	2	-
All Deathsn=108 Participants	2	-
ABBV-8E12 1000 mgAny TEAEn=116 Participants	108	-
Severe TEAEn=116 Participants	14	-
TEAE With a Reasonable Possibility to Study Drugn=116 Participants	31	-
SAEn=116 Participants	22	-
TEAE Leading to Discontinuation of Study Drugn=116 Participants	6	-
Fatal TEAEn=116 Participants	2	-
All Deathsn=116 Participants	2	-
ABBV-8E12 2000 mgAny TEAEn=113 Participants	104	-
Severe TEAEn=113 Participants	11	-
TEAE With a Reasonable Possibility to Study Drugn=113 Participants	33	-
SAEn=113 Participants	17	-
TEAE Leading to Discontinuation of Study Drugn=113 Participants	4	-
Fatal TEAEn=113 Participants	1	-
All Deathsn=113 Participants	1	-

Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time frame:Day 1 (Dose 1): Pre-infusion, post-infusion (within 15 minutes), 1 and 2 hours post-infusion; Days 5 and 15. Day 85 (Dose 4): Pre-infusion (0 hour), post-infusion (within 15 minutes) and 1 and 2 hours post-infusion; Days 89 and 99.

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

time to event, event

Secondary/protocol endpoint

Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Secondary/protocol endpoint

Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Secondary/registry result

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg/mL	Geometric coefficient of variation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	108	28
Fourth Dosing Intervaln=11 Participants	168	23
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	284	21
Fourth Dosing Intervaln=17 Participants	426	20
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	528	27
Fourth Dosing Intervaln=8 Participants	806	37

Secondary/registry result

Time to Cmax (Tmax) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	3	-1.8 - 4.2
Fourth Dosing Intervaln=11 Participants	2.4	-1.1 - 4.1
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	2.5	-1.3 - 4.2
Fourth Dosing Intervaln=17 Participants	2.5	-1.7 - 4.3
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	2.7	-1.7 - 3.6
Fourth Dosing Intervaln=8 Participants	2.3	-1.7 - 3.6

Secondary/registry result

Half-Life (T1/2) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Posted result

Group	Value (mean), days	Standard deviation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	22.0	17.2
Fourth Dosing Intervaln=11 Participants	19.6	6.09
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	19.4	8.87
Fourth Dosing Intervaln=17 Participants	24.0	16.6
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	33.2	10.5
Fourth Dosing Intervaln=8 Participants	37.5	13.5

Secondary/registry result

Cmax/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg/mL/mg	Geometric coefficient of variation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	0.359	28
Fourth Dosing Intervaln=11 Participants	0.561	23
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	0.284	21
Fourth Dosing Intervaln=17 Participants	0.426	20
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	0.264	27
Fourth Dosing Intervaln=8 Participants	0.403	37

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Secondary/protocol endpoint/low confidence

Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

Time frame:Day 1 (Dose 1): pre-infusion, up to Day 29 (trough level before Dose 2). Day 85 (Dose 4): pre-infusion, up to Day 113 (trough level before Dose 5). See Outcome Measure description above for complete time point details.

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

descriptive

Secondary/registry result/low confidence

Serum Concentration at the End of a Dose Interval (Ctrough) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg/mL	Geometric coefficient of variation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	28.6	22
Fourth Dosing Intervaln=11 Participants	56.4	25
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	75.1	33
Fourth Dosing Intervaln=17 Participants	182	29
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	163	26
Fourth Dosing Intervaln=8 Participants	320	36

Secondary/registry result/low confidence

Area Under the Concentration-Time Curve From Dosing (Time 0) to Day 28 (AUC0-28) for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg.day/mL	Geometric coefficient of variation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	2520	28
Fourth Dosing Intervaln=11 Participants	4230	33
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	6090	37
Fourth Dosing Intervaln=17 Participants	13100	36
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	14800	25
Fourth Dosing Intervaln=8 Participants	30200	36

Secondary/registry result/low confidence

AUC0-28/Dose for ABBV-8E12 Over the Dosing Interval After the First and Fourth Doses

descriptive

Posted result

Group	Value (geometric_mean), µg.day/mL/mg	Geometric coefficient of variation
ABBV-8E12 300 mgFirst Dosing Intervaln=12 Participants	8.40	28
Fourth Dosing Intervaln=11 Participants	14.1	33
ABBV-8E12 1000 mgFirst Dosing Intervaln=17 Participants	6.09	37
Fourth Dosing Intervaln=17 Participants	13.1	36
ABBV-8E12 2000 mgFirst Dosing Intervaln=9 Participants	7.41	25
Fourth Dosing Intervaln=8 Participants	15.1	36

Secondary/protocol endpoint/low confidence

Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline Over Time in University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) - Total Score

Time frame:Baseline, Week 48, Week 96

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboChange to Week 48n=98 Participants	-4.47	1.533
Change to Week 96n=77 Participants	-13.36	2.047
ABBV-8E12 300 mgChange to Week 48n=93 Participants	-6.04	1.567
Change to Week 96n=79 Participants	-12.74	2.037
ABBV-8E12 1000 mgChange to Week 48n=102 Participants	-4.10	1.500
Change to Week 96n=81 Participants	-11.55	1.994
ABBV-8E12 2000 mgChange to Week 48n=88 Participants	-8.96	1.601
Change to Week 96n=73 Participants	-14.85	2.104

LS Mean of Difference-1.5795% CI-5.851 - 2.703p0.470repeated measures model

Week 48

Effect size/pooled SD-0.10

Week 48

LS Mean of Difference0.3695% CI-3.819 - 4.548p0.864repeated measures model

Week 48

Effect size/pooled SD0.02

Week 48

LS Mean of Difference-4.4995% CI-8.826 - -0.150p0.043repeated measures model

Week 48

Effect size/pooled SD-0.28

Week 96

LS Mean of Difference0.6195% CI-5.041 - 6.270p0.831repeated measures model

Week 96

Effect size/pooled SD0.03

Week 96

LS Mean of Difference1.8195% CI-3.784 - 7.404p0.525repeated measures model

Week 96

Effect size/pooled SD0.10

Week 96

LS Mean of Difference-1.4995% CI-7.239 - 4.255p0.610repeated measures model

Week 96

Effect size/pooled SD-0.08

Week 96

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Wang D, Florian H, Lynch SY, Robieson W, Zhuang R, Kusiak C, Ross JL, Walsh JR, Graff O. Using AI-generated digital twins to boost clinical trial efficiency in Alzheimer's disease. Alzheimers Dement (N Y). 2025 Nov 22;11(4):e70181. doi: 10.1002/trc2.70181. eCollection 2025 Oct-Dec.
PMID41281734via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.