DIAN-TU

CompletedPhase 2 / PHASE3Results posted

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation.

A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease

Lead sponsor

Washington University School of Medicine

Assets

Gantenerumab / Solanezumab

Listed sites

Recruiting sites

Enrollment

194

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Mini-Mental State Examination (MMSE)

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

Org study IDDIAN-TU-001 (gant-sola)

NCT IDNCT04623242

Timeline

Milestones

Study start2012-12actual (month precision)

Primary completion2019-11-22actual

Study completion2020-03-06actual

Study first posted2020-11-10actual

Last update posted2022-09-22actual

Results first posted2022-09-22actual

Assets

Drug assets

Gantenerumab Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Between 18-80 years of age

•Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family.

•Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset.

•Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)

•Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning

•Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.

•For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).

•Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.

•Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion

Exclusion criteria

•History or presence of brain MRI scans indicative of any other significant abnormality

•Alcohol or drug dependence currently or within the past 1 year

•Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.

•History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders

•Anticoagulants except low dose (≤ 325 mg) aspirin.

•Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.

•History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.

•Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.

•Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Endpoints (86)

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

Amyloid biomarkers

Neuroimaging

Fluid / digital biomarkers

Tau biomarkers

Neurodegeneration biomarkers

Memory

Function / daily living

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

40 endpoints

Primary/protocol endpoint

Assess Cognitive Efficacy in Individuals With Mutations Causing Dominantly Inherited AD as Measured by the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE);

Time frame:Baseline through Week 260

Mini-Mental State Examination (MMSE)

descriptive

Primary/registry result

Assess Cognitive Efficacy in Individuals With Mutations Causing Dominantly Inherited AD as Measured by the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE);

Time frame:Baseline through Week 260

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (mean), Ratio	Standard deviation
Gantenerumab vs. Mutation Positive Placebon=161 Participants	1.063	0.059
Solanezumab vs. Mutation Positive Placebon=160 Participants	1.255	0.061

Ratio1.063

Ratio1.255

Secondary/protocol endpoint

Gantenerumab: Rate of Change Over Time- Clinical Dementia Rating Sum of Boxes (CDR-SB)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

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

descriptive

Secondary/protocol endpoint

Solanezumab: Clinical Measures- Clinical Dementia Rating (CDR)

Time frame:Baseline and Weeks 52, 104, 156, and 208

event count, event

Secondary/protocol endpoint

Solanezumab: Clinical Measures- CDR Sum of Boxes (CDR-SB)

Time frame:Baseline and Weeks 52, 104, 156, and 208

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

descriptive

Secondary/protocol endpoint

Solanezumab: Clinical Measures- Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Solanezumab: Clinical Measures- Functional Assessment Scale (FAS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

change from baseline, improvement

Secondary/protocol endpoint

Solanezumab: Clinical Measures- Mini-Mental Status State Examination (MMSE)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- International Shopping List Task 30-Minute Delayed Recall

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Groton Maze Learning Test 30 Minute Delayed Recall

Time frame:Baseline, Week 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Groton Maze Learning Test Delayed Reversed Recall

Time frame:Baseline, Week 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Trailmaking Test Part A

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Trailmaking Test Part B

Time frame:Baseline, Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- WAIS-R Digit-Symbol Substitution Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- WMS-R Digit Span Backward

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- WMS-R Digit Span Forward

Time frame:Baseline, Weeks 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Raven's Progressive Matrices (Set A)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Category Fluency (Animals)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Category Fluency (Vegetables)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- WMS-R Logical Memory Delayed Recall Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- WMS-R Logical Memory Immediate Recall Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/registry result

Gantenerumab: Rate of Change Over Time- Clinical Dementia Rating Sum of Boxes (CDR-SB)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

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

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
GantenerumabWeek 52n=52 Participants	0.74	0.202
Week 104n=46 Participants	1.27	0.364
Week 156n=41 Participants	1.95	0.511
Week 208n=36 Participants	2.96	0.726
Week 260n=13 Participants	4.61	1.220
Mutation Positive PlacebosWeek 52n=40 Participants	0.44	0.231
Week 104n=36 Participants	1.36	0.414
Week 156n=32 Participants	2.28	0.580
Week 208n=30 Participants	3.24	0.819
Week 260n=7 Participants	5.76	1.437

Mean Difference (Final Values)-0.2795% CI-2.46 - 1.92p0.805t-test, 2 sided

Secondary/registry result

Solanezumab: Clinical Measures- Clinical Dementia Rating (CDR)

Time frame:Baseline and Weeks 52, 104, 156, and 208

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
SolanezumabWeek 52 · Increase from baseline CDR Global Scoren=49 Participants	11	-
Week 52 · No increase from baseline CDR Global Scoren=49 Participants	38	-
Week 104 · Increase from baseline CDR Global Scoren=47 Participants	18	-
Week 104 · No increase from baseline CDR Global Scoren=47 Participants	29	-
Week 156 · Increase from baseline CDR Global Scoren=42 Participants	16	-
Week 156 · No increase from baseline CDR Global Scoren=42 Participants	26	-
Week 208 · Increase from baseline CDR Global Scoren=36 Participants	12	-
Week 208 · No increase from baseline CDR Global Scoren=36 Participants	24	-
Week 260 · Increase from baseline CDR Global Scoren=13 Participants	5	-
Week 260 · No increase from baseline CDR Global Scoren=13 Participants	8	-
Mutation Positive PlacebosWeek 52 · Increase from baseline CDR Global Scoren=40 Participants	8	-
Week 52 · No increase from baseline CDR Global Scoren=40 Participants	32	-
Week 104 · Increase from baseline CDR Global Scoren=36 Participants	8	-
Week 104 · No increase from baseline CDR Global Scoren=36 Participants	28	-
Week 156 · Increase from baseline CDR Global Scoren=32 Participants	13	-
Week 156 · No increase from baseline CDR Global Scoren=32 Participants	19	-
Week 208 · Increase from baseline CDR Global Scoren=30 Participants	8	-
Week 208 · No increase from baseline CDR Global Scoren=30 Participants	22	-
Week 260 · Increase from baseline CDR Global Scoren=7 Participants	3	-
Week 260 · No increase from baseline CDR Global Scoren=7 Participants	4	-

Ratio0.3443p0.5573Chi-squared

Secondary/registry result

Solanezumab: Clinical Measures- CDR Sum of Boxes (CDR-SB)

Time frame:Baseline and Weeks 52, 104, 156, and 208

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

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.90	0.208
Week 104n=47 Participants	1.87	0.367
Week 156n=42 Participants	2.55	0.512
Week 208n=36 Participants	3.65	0.723
Week 260n=13 Participants	4.87	1.212
Mutation Positive PlacebosWeek 52n=40 Participants	0.44	0.231
Week 104n=36 Participants	1.36	0.414
Week 156n=32 Participants	2.28	0.580
Week 208n=30 Participants	3.24	0.819
Week 260n=7 Participants	5.76	1.437

Mean Difference (Final Values)0.4195% CI-1.77 - 2.60p0.707t-test, 2 sided

Secondary/registry result

Solanezumab: Clinical Measures- Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.49	0.416
Week 104n=47 Participants	0.70	0.463
Week 156n=42 Participants	1.31	0.459
Week 208n=36 Participants	2.11	0.575
Week 260n=13 Participants	1.83	0.934
Mutation Positive PlacebosWeek 52n=40 Participants	1.06	0.460
Week 104n=35 Participants	1.54	0.530
Week 156n=32 Participants	1.10	0.522
Week 208n=30 Participants	1.74	0.639
Week 260n=7 Participants	1.16	1.212

Mean Difference (Final Values)0.3695% CI-1.34 - 2.07p0.674t-test, 2 sided

Secondary/registry result

Solanezumab: Clinical Measures- Functional Assessment Scale (FAS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=43 Participants	0.68	0.430
Week 104n=42 Participants	2.21	0.690
Week 156n=38 Participants	3.03	0.926
Week 208n=35 Participants	4.33	1.208
Week 260n=12 Participants	5.82	1.748
Mutation Positive PlacebosWeek 52n=36 Participants	1.40	0.469
Week 104n=31 Participants	2.44	0.790
Week 156n=29 Participants	4.07	1.061
Week 208n=27 Participants	5.55	1.373
Week 260n=7 Participants	5.69	2.073

Mean Difference (Final Values)-1.2295% CI-4.86 - 2.42p0.507t-test, 2 sided

Secondary/registry result

Solanezumab: Clinical Measures- Mini-Mental Status State Examination (MMSE)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	-1.30	0.354
Week 104n=47 Participants	-2.59	0.603
Week 156n=40 Participants	-3.76	0.858
Week 208n=36 Participants	-5.31	1.137
Week 260n=13 Participants	-7.88	1.799
Mutation Positive PlacebosWeek 52n=40 Participants	-0.83	0.391
Week 104n=36 Participants	-1.73	0.677
Week 156n=32 Participants	-3.23	0.964
Week 208n=30 Participants	-4.30	1.275
Week 260n=7 Participants	-5.94	2.143

Mean Difference (Final Values)-1.0295% CI-4.41 - 2.38p0.553t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- International Shopping List Task 30-Minute Delayed Recall

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=47 Participants	-0.35	0.248
Week 104n=47 Participants	-0.98	0.300
Week 156n=40 Participants	-1.55	0.294
Week 208n=35 Participants	-1.92	0.396
Week 260n=12 Participants	-1.45	0.548
Mutation Positive PlacebosWeek 52n=40 Participants	-0.17	0.274
Week 104n=35 Participants	-0.64	0.343
Week 156n=31 Participants	-0.42	0.333
Week 208n=28 Participants	-0.93	0.447
Week 260n=7 Participants	-1.86	0.680

Mean Difference (Final Values)-1.0095% CI-2.18 - 0.19p0.098t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Groton Maze Learning Test 30 Minute Delayed Recall

Time frame:Baseline, Week 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), count of errors	Standard error
SolanezumabWeek 52n=40 Participants	1.00	0.975
Week 104n=37 Participants	1.16	1.108
Week 156n=35 Participants	2.40	1.055
Week 208n=32 Participants	4.33	1.319
Week 260n=12 Participants	5.11	2.894
Mutation Positive PlacebosWeek 52n=36 Participants	-0.13	1.043
Week 104n=31 Participants	0.78	1.207
Week 156n=27 Participants	0.96	1.181
Week 208n=24 Participants	1.60	1.470
Week 260n=6 Participants	6.99	3.861

Mean Difference (Final Values)2.7395% CI-1.22 - 6.68p0.173t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Groton Maze Learning Test Delayed Reversed Recall

Time frame:Baseline, Week 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), number of errors	Standard error
SolanezumabWeek 52n=40 Participants	7.08	2.686
Week 104n=37 Participants	6.21	2.715
Week 156n=35 Participants	6.45	2.490
Week 208n=32 Participants	5.59	2.658
Week 260n=12 Participants	14.25	10.722
Mutation Positive PlacebosWeek 52n=36 Participants	-1.34	2.858
Week 104n=31 Participants	3.28	2.912
Week 156n=28 Participants	1.82	2.711
Week 208n=24 Participants	5.29	2.980
Week 260n=6 Participants	6.75	15.509

Mean Difference (Final Values)0.3095% CI-8.10 - 8.71p0.940t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Trailmaking Test Part A

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), seconds	Standard error
SolanezumabWeek 52n=49 Participants	9.73	2.895
Week 104n=45 Participants	15.03	4.473
Week 156n=35 Participants	19.45	5.832
Week 208n=33 Participants	35.69	11.028
Week 260n=13 Participants	93.49	27.664
Mutation Positive PlacebosWeek 52n=40 Participants	5.14	3.227
Week 104n=33 Participants	11.38	5.039
Week 156n=28 Participants	15.21	6.538
Week 208n=25 Participants	32.63	12.430
Week 260n=6 Participants	89.02	32.699

Mean Difference (Final Values)3.0795% CI-30.49 - 36.62p0.854t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Trailmaking Test Part B

Time frame:Baseline, Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), number of seconds	Standard error
SolanezumabWeek 52n=41 Participants	-2.39	6.582
Week 104n=36 Participants	-0.20	7.626
Week 156n=33 Participants	21.59	11.619
Week 208n=29 Participants	21.42	11.539
Week 260n=12 Participants	53.44	25.139
Mutation Positive PlacebosWeek 52n=33 Participants	8.00	7.371
Week 104n=27 Participants	10.52	8.710
Week 156n=23 Participants	21.35	13.470
Week 208n=23 Participants	16.54	13.211
Week 260n=5 Participants	37.62	33.565

Mean Difference (Final Values)4.8895% CI-30.00 - 39.75p0.781t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- WAIS-R Digit-Symbol Substitution Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.35	1.149
Week 104n=41 Participants	-0.97	1.744
Week 156n=34 Participants	-3.64	2.232
Week 208n=33 Participants	-7.83	2.784
Week 260n=13 Participants	-12.96	4.057
Mutation Positive PlacebosWeek 52n=39 Participants	-1.02	1.283
Week 104n=32 Participants	0.20	1.965
Week 156n=26 Participants	-1.72	2.540
Week 208n=26 Participants	-6.15	3.170
Week 260n=6 Participants	-9.60	4.898

Mean Difference (Final Values)-1.6995% CI-10.05 - 6.67p0.689t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- WMS-R Digit Span Backward

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), number of correct sequences recalled	Standard error
SolanezumabWeek 52n=49 Participants	0.06	0.241
Week 104n=47 Participants	-0.41	0.272
Week 156n=40 Participants	-1.14	0.370
Week 208n=34 Participants	-1.17	0.460
Week 260n=12 Participants	-1.17	0.657
Mutation Positive PlacebosWeek 52n=40 Participants	-0.12	0.267
Week 104n=35 Participants	-0.16	0.310
Week 156n=32 Participants	-0.28	0.415
Week 208n=28 Participants	-0.68	0.513
Week 260n=6 Participants	-1.22	0.832

Mean Difference (Final Values)-0.4995% CI-1.86 - 0.87p0.474t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- WMS-R Digit Span Forward

Time frame:Baseline, Weeks 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), number of correct sequences recalled	Standard error
SolanezumabWeek 52n=49 Participants	-0.76	0.220
Week 104n=47 Participants	-1.03	0.290
Week 156n=40 Participants	-1.50	0.346
Week 208n=35 Participants	-1.96	0.424
Week 260n=13 Participants	-2.05	0.722
Mutation Positive PlacebosWeek 52n=40 Participants	-0.38	0.242
Week 104n=35 Participants	-0.84	0.329
Week 156n=32 Participants	-1.23	0.387
Week 208n=28 Participants	-1.86	0.475
Week 260n=6 Participants	-1.06	0.929

Mean Difference (Final Values)-0.0995% CI-1.36 - 1.17p0.886t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Raven's Progressive Matrices (Set A)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	-0.47	0.235
Week 104n=46 Participants	-0.93	0.310
Week 156n=38 Participants	-1.38	0.366
Week 208n=34 Participants	-1.44	0.372
Week 260n=13 Participants	-3.11	0.873
Mutation Positive PlacebosWeek 52n=39 Participants	-0.70	0.261
Week 104n=34 Participants	-0.63	0.350
Week 156n=31 Participants	-1.06	0.408
Week 208n=27 Participants	-1.53	0.416
Week 260n=6 Participants	-1.78	1.124

Mean Difference (Final Values)0.0995% CI-1.03 - 1.20p0.873t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Category Fluency (Animals)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	-1.86	0.642
Week 104n=47 Participants	-1.64	0.754
Week 156n=40 Participants	-2.84	0.869
Week 208n=35 Participants	-4.69	1.105
Week 260n=13 Participants	-5.45	1.761
Mutation Positive PlacebosWeek 52n=40 Participants	-2.19	0.711
Week 104n=35 Participants	-2.50	0.860
Week 156n=32 Participants	-2.46	0.974
Week 208n=28 Participants	-3.27	1.239
Week 260n=6 Participants	-6.50	2.303

Mean Difference (Final Values)-1.4295% CI-4.71 - 1.87p0.394t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- Category Fluency (Vegetables)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

event count, event

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	-0.83	0.481
Week 104n=47 Participants	-1.22	0.539
Week 156n=40 Participants	-1.29	0.555
Week 208n=35 Participants	-2.03	0.707
Week 260n=13 Participants	-3.36	1.069
Mutation Positive PlacebosWeek 52n=40 Participants	-1.41	0.533
Week 104n=35 Participants	-1.74	0.619
Week 156n=32 Participants	-1.43	0.623
Week 208n=28 Participants	-1.72	0.794
Week 260n=6 Participants	-2.23	1.386

Mean Difference (Final Values)-0.3095% CI-2.41 - 1.81p0.776t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- WMS-R Logical Memory Delayed Recall Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.64	0.397
Week 104n=47 Participants	1.25	0.501
Week 156n=41 Participants	1.21	0.549
Week 208n=35 Participants	0.84	0.606
Week 260n=13 Participants	0.40	1.029
Pooled PlaceboWeek 52n=40 Participants	1.33	0.441
Week 104n=34 Participants	1.71	0.576
Week 156n=32 Participants	2.37	0.618
Week 208n=28 Participants	1.82	0.678
Week 260n=6 Participants	2.68	1.416

Mean Difference (Final Values)-0.9895% CI-2.78 - 0.82p0.283t-test, 2 sided

Secondary/registry result

Solanezumab: Cognitive Measures- WMS-R Logical Memory Immediate Recall Test

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.40	0.452
Week 104n=47 Participants	0.73	0.510
Week 156n=41 Participants	0.13	0.573
Week 208n=35 Participants	0.24	0.631
Week 260n=13 Participants	-0.56	1.018
Mutation Positive PlacebosWeek 52n=40 Participants	-0.06	0.501
Week 104n=35 Participants	0.75	0.579
Week 156n=32 Participants	0.91	0.646
Week 208n=28 Participants	0.69	0.707
Week 260n=6 Participants	1.37	1.420

Mean Difference (Final Values)-0.4595% CI-2.33 - 1.42p0.634t-test, 2 sided

Memory

2 endpoints

Secondary/protocol endpoint

Solanezumab: Cognitive Measures- Composite Including: Alternative Multivariate Composite: (1) Digit Span Backwards; (2) Logical Memory (Immediate); (3) Trailmaking B; (4) Category Fluency (Animals)

Time frame:Baseline through Week 260

categorical status, descriptive

Secondary/registry result

Solanezumab: Cognitive Measures- Composite Including: Alternative Multivariate Composite: (1) Digit Span Backwards; (2) Logical Memory (Immediate); (3) Trailmaking B; (4) Category Fluency (Animals)

Time frame:Baseline through Week 260

categorical status, descriptive

Posted result

Group	Value (mean), Ratio	Standard deviation
Solanezumab vs. Mutation Positive Placebo Plus DIAN-OBS Control Groupn=160 Participants	1.155	0.074

Ratio1.155

Function / daily living

2 endpoints

Secondary/protocol endpoint

Gantenerumab: Rate of Change Over Time- Functional Assessment Scale (FAS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

change from baseline, improvement

Secondary/registry result

Gantenerumab: Rate of Change Over Time- Functional Assessment Scale (FAS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
GantenerumabWeek 52n=48 Participants	1.23	0.408
Week 104n=42 Participants	2.34	0.680
Week 156n=37 Participants	3.45	0.921
Week 208n=34 Participants	4.34	1.202
Week 260n=13 Participants	6.40	1.730
Mutation Positive PlacebosWeek 52n=36 Participants	1.40	0.469
Week 104n=31 Participants	2.44	0.790
Week 156n=29 Participants	4.07	1.061
Week 208n=27 Participants	5.55	1.373
Week 260n=7 Participants	5.69	2.073

Mean Difference (Final Values)-1.2095% CI-4.83 - 2.43p0.512t-test, 2 sided

Test of equality (any treatment difference)

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Solanezumab: Clinical Measures- Geriatric Depression Scale (GDS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/registry result

Solanezumab: Clinical Measures- Geriatric Depression Scale (GDS)

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
SolanezumabWeek 52n=49 Participants	0.20	0.230
Week 104n=47 Participants	0.06	0.265
Week 156n=39 Participants	-0.22	0.250
Week 208n=35 Participants	-0.12	0.294
Week 260n=13 Participants	-0.16	0.544
Mutation Positive PlacebosWeek 52n=40 Participants	-0.14	0.255
Week 104n=35 Participants	0.03	0.304
Week 156n=32 Participants	-0.07	0.276
Week 208n=28 Participants	0.36	0.328
Week 260n=6 Participants	0.66	0.820

Mean Difference (Final Values)-0.4795% CI-1.35 - 0.40p0.283t-test, 2 sided

Amyloid biomarkers

14 endpoints

Secondary/protocol endpoint

Gantenerumab: Imaging Measures Composite [11C] PiB Partial Volume Corrected Regional Spread Function Standardized Uptake Value Ratio - Composite

Time frame:Baseline, Weeks 52, 104 and 208

ratio, descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by [11C]PiB-PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

ratio, descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by Florbetapir PET

Time frame:Weeks104 and 208

ratio, descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Glucose Metabolism as Measured by Fluorodeoxyglucose (FDG)-PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

ratio, descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF Aβ 40 Free Change From Baseline

Time frame:Baseline and Weeks 52, 104 and 208

change from baseline, improvement

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF Aβ 42 Total

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF Aβ 40 Total

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/registry result

Gantenerumab: Imaging Measures Composite [11C] PiB Partial Volume Corrected Regional Spread Function Standardized Uptake Value Ratio - Composite

Time frame:Baseline, Weeks 52, 104 and 208

ratio, descriptive

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
GantenerumabWeek 52n=47 Participants	-0.006	0.0402
Week 104n=40 Participants	-0.106	0.0422
Week 208n=33 Participants	-0.334	0.0736
Mutation Positive PlacebosWeek 52n=37 Participants	0.103	0.0454
Week 104n=33 Participants	0.134	0.0470
Week 208n=25 Participants	0.306	0.0839

Median Difference (Final Values)-0.64195% CI-0.864 - -0.417p<0.001t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by [11C]PiB-PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

ratio, descriptive

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
SolanezumabWeek 52n=46 Participants	0.030	0.0147
Week 104n=41 Participants	0.019	0.0180
Week 208n=27 Participants	0.113	0.0387
Mutation Positive PlacebosWeek 52n=37 Participants	0.025	0.0164
Week 104n=33 Participants	0.022	0.0200
Week 208n=25 Participants	0.093	0.0408

Mean Difference (Final Values)0.02095% CI-0.093 - 0.132p0.726t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Brain Amyloid Load as Measured by Florbetapir PET

Time frame:Weeks104 and 208

ratio, descriptive

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
SolanezumabWeek 104n=36 Participants	0.066	0.0458
Week 208n=28 Participants	0.251	0.0717
Mutation Positive PlacebosWeek 104n=29 Participants	0.105	0.0511
Week 208n=24 Participants	0.168	0.0775

Mean Difference (Final Values)0.08295% CI-0.130 - 0.295p0.439t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Brain Glucose Metabolism as Measured by Fluorodeoxyglucose (FDG)-PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

ratio, descriptive

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
SolanezumabWeek 52n=43 Participants	-0.021	0.0072
Week 104n=42 Participants	-0.047	0.0063
Week 208n=31 Participants	-0.074	0.0110
Mutation Positive PlacebosWeek 52n=33 Participants	-0.030	0.0083
Week 104n=31 Participants	-0.043	0.0074
Week 208n=23 Participants	-0.074	0.0127

Mean Difference (Final Values)0.00195% CI-0.034 - 0.033p0.967t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF Aβ 40 Free Change From Baseline

Time frame:Baseline and Weeks 52, 104 and 208

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=41 Participants	-1613.48	185.134
Week 104n=42 Participants	-2237.73	177.616
Week 208n=24 Participants	-2567.13	229.807
Solanezumab Direct PlaceboWeek 52n=18 Participants	-856.65	284.584
Week 104n=15 Participants	-1398.13	290.994
Week 208n=13 Participants	-631.22	307.331

Mean Difference (Final Values)-1935.9195% CI-2717.64 - -1154.18p<0.001t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF Aβ 42 Total

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=39 Participants	558.91	44.533
Week 104n=40 Participants	623.16	41.301
Week 208n=27 Participants	1352.83	75.447
Solanezumab Direct PlaceboWeek 52n=17 Participants	44.81	69.142
Week 104n=14 Participants	89.32	68.119
Week 208n=12 Participants	66.48	118.662

Mean Difference (Final Values)1286.3595% CI1002.79 - 1569.90p<0.001t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF Aβ 40 Total

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=42 Participants	3676.97	403.908
Week 104n=42 Participants	4017.93	331.917
Week 208n=29 Participants	9723.95	669.037
Solanezumab Direct PlaceboWeek 52n=18 Participants	-414.57	625.000
Week 104n=15 Participants	-594.08	549.240
Week 208n=13 Participants	-143.31	1011.672

Mean Difference (Final Values)9867.2695% CI7419.38 - 12315.15p<0.001t-test, 2 sided

Tau biomarkers

4 endpoints

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Tau Load as Measured by Flortaucipir PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF pTau 181

Time frame:Baseline and Weeks 52, 104 and 208

Phosphorylated tau 181 (p-tau181)

concentration, descriptive

Secondary/registry result

Solanezumab: Imaging Measures- Brain Tau Load as Measured by Flortaucipir PET Non-partial Volume Corrected

Time frame:Baseline and Weeks 52, 104 and 208

descriptive

Posted result

Group	Value (mean), Ratio	Standard deviation
SolanezumabBaselinen=7 Participants	1.77391	0.548324
Week 52n=21 Participants	1.46020	0.503595
Change in Baseline in Week 52n=6 Participants	0.11302	0.221413
Week 104n=28 Participants	1.49990	0.506423
Change from Baseline Week 104n=6 Participants	0.15450	0.252682
Week 208n=19 Participants	1.43263	0.402563
Change from Baseline Week 208n=2 Participants	0.05275	0.052679
Mutation Positive PlacebosBaselinen=6 Participants	1.52502	0.582485
Week 52n=19 Participants	1.49041	0.434475
Change in Baseline in Week 52n=6 Participants	-0.03925	0.192448
Week 104n=21 Participants	1.42231	0.394000
Change from Baseline Week 104n=4 Participants	0.01208	0.263170
Week 208n=12 Participants	1.28081	0.295191
Change from Baseline Week 208n=2 Participants	0.05825	0.023688

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF pTau 181

Time frame:Baseline and Weeks 52, 104 and 208

Phosphorylated tau 181 (p-tau181)

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=45 Participants	0.26	2.951
Week 104n=43 Participants	4.91	2.903
Week 208n=32 Participants	6.90	4.447
Mutation Positive PlacebosWeek 52n=37 Participants	-0.18	3.254
Week 104n=34 Participants	4.25	3.290
Week 208n=29 Participants	7.65	4.907

Mean Difference (Final Values)-0.7695% CI-13.97 - 12.45p0.909t-test, 2 sided

Neurodegeneration biomarkers

4 endpoints

Secondary/protocol endpoint

Solanezumab: Change From Baseline Fluid Biomarker Measures- CSF Neurofilament Light Chain (NfL)

Time frame:Baseline and Weeks 52, 104 and 208

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- Plasma Neurofilament Light Chain (NfL)

Time frame:Baseline and Weeks 52, 104 and 208

Neurofilament light (NfL)

concentration, descriptive

Secondary/registry result

Solanezumab: Change From Baseline Fluid Biomarker Measures- CSF Neurofilament Light Chain (NfL)

Time frame:Baseline and Weeks 52, 104 and 208

Neurofilament light (NfL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=44 Participants	0.102	0.0414
Week 104n=42 Participants	0.191	0.0314
Week 208n=31 Participants	0.426	0.0402
Mutation Positive PlacebosWeek 52n=35 Participants	0.144	0.0463
Week 104n=33 Participants	0.159	0.0354
Week 208n=28 Participants	0.248	0.0435

Mean Difference (Final Values)0.17895% CI0.059 - 0.296p0.004t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- Plasma Neurofilament Light Chain (NfL)

Time frame:Baseline and Weeks 52, 104 and 208

Neurofilament light (NfL)

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=37 Participants	0.47	1.864
Week 104n=32 Participants	1.22	0.799
Week 208n=26 Participants	3.29	0.959
Mutation Positive PlacebosWeek 52n=36 Participants	4.03	1.893
Week 104n=33 Participants	3.15	0.780
Week 208n=26 Participants	3.72	0.960

Mean Difference (Final Values)-0.4395% CI-3.21 - 2.35p0.754t-test, 2 sided

Neuroimaging

8 endpoints

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Cortical Thickness of Regions of Interest - Precuneus Region

Time frame:Baseline and Weeks 52, 104, 156 and 208

descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Volumetric MRI Combined Total Volume Corrected for Head Size - Hippocampus Volume

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Whole Brain Volume Corrected for Head Size

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/protocol endpoint

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Ventricular Volume (Volumetric MRI) Corrected for Head Size

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Secondary/registry result

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Cortical Thickness of Regions of Interest - Precuneus Region

Time frame:Baseline and Weeks 52, 104, 156 and 208

descriptive

Posted result

Group	Value (least_squares_mean), Millimeters	Standard error
SolanezumabWeek 52n=46 Participants	-0.033	0.0106
Week 104n=43 Participants	-0.067	0.0142
Week 156n=36 Participants	-0.110	0.0193
Week 208n=32 Participants	-0.138	0.0254
Mutation Positive PlacebosWeek 52n=38 Participants	-0.053	0.0114
Week 104n=35 Participants	-0.090	0.0156
Week 156n=29 Participants	-0.122	0.0214
Week 208n=28 Participants	-0.154	0.0279

Mean Difference (Final Values)0.01695% CI-0.059 - 0.092p0.669t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Volumetric MRI Combined Total Volume Corrected for Head Size - Hippocampus Volume

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), Cubic Millimeters	Standard error
SolanezumabWeek 52n=46 Participants	-106.74	71.081
Week 104n=43 Participants	-341.35	72.549
Week 156n=36 Participants	-524.14	76.210
Week 208n=32 Participants	-706.41	78.746
Week 260n=10 Participants	-977.91	116.633
Mutation Positive PlacebosWeek 52n=38 Participants	-153.34	78.529
Week 104n=35 Participants	-302.58	80.556
Week 156n=29 Participants	-541.76	84.861
Week 208n=28 Participants	-671.95	85.672
Week 260n=7 Participants	-551.42	137.366

Mean Difference (Final Values)-34.4695% CI-264.14 - 195.22p0.768t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Whole Brain Volume Corrected for Head Size

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), Cubic Millimeters	Standard error
SolanezumabWeek 52n=46 Participants	-11990.31	4027.589
Week 104n=43 Participants	-19808.05	4106.838
Week 156n=36 Participants	-32713.22	4304.849
Week 208n=32 Participants	-39306.90	4446.803
Week 260n=10 Participants	-54558.23	6562.583
Mutation Positive PlacebosWeek 52n=38 Participants	-10578.56	4409.442
Week 104n=35 Participants	-22147.27	4524.072
Week 156n=29 Participants	-30590.95	4770.402
Week 208n=28 Participants	-36569.28	4816.319
Week 260n=7 Participants	-50077.53	7713.907

Mean Difference (Final Values)-2737.6295% CI-15678.06 - 10202.81p0.677t-test, 2 sided

Secondary/registry result

Solanezumab: Imaging Measures- Brain Atrophy as Measured by Ventricular Volume (Volumetric MRI) Corrected for Head Size

Time frame:Baseline and Weeks 52, 104, 156, 208 and 260

descriptive

Posted result

Group	Value (least_squares_mean), Cubic Millimeters	Standard error
SolanezumabWeek 52n=46 Participants	1815.99	1067.526
Week 104n=43 Participants	2972.85	1094.409
Week 156n=36 Participants	5705.59	1163.978
Week 208n=32 Participants	8755.04	1212.184
Week 260n=10 Participants	12332.3	1907.752
Mutation Positive PlacebosWeek 52n=38 Participants	1796.78	1182.631
Week 104n=35 Participants	4452.69	1218.440
Week 156n=29 Participants	6729.64	1297.406
Week 208n=28 Participants	9833.37	1312.937
Week 260n=7 Participants	11456.61	2258.240

Mean Difference (Final Values)-1078.3295% CI-4603.28 - 2446.64p0.547t-test, 2 sided

Fluid / digital biomarkers

8 endpoints

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF Aβ 42 Free

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- CSF Tau

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- Total Plasma Aβ 1-40

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/protocol endpoint

Solanezumab: Fluid Biomarker Measures- Total Plasma Aβ 42

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF Aβ 42 Free

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=40 Participants	-109.33	24.235
Week 104n=40 Participants	-172.55	14.535
Week 208n=19 Participants	-250.78	13.935
Solanezumab Direct PlaceboWeek 52n=17 Participants	-79.35	37.602
Week 104n=14 Participants	-125.64	24.402
Week 208n=11 Participants	-173.66	18.204

Mean Difference (Final Values)-77.1295% CI-124.56 - -29.68p0.003t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- CSF Tau

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=38 Participants	4.73	14.884
Week 104n=38 Participants	31.74	15.649
Week 208n=29 Participants	59.08	24.691
Mutation Positive PlacebosWeek 52n=35 Participants	-6.60	15.553
Week 104n=32 Participants	23.24	16.783
Week 208n=28 Participants	28.19	25.579

Mean Difference (Final Values)30.8995% CI-40.04 - 101.83p0.388t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- Total Plasma Aβ 1-40

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=45 Participants	168588.48	5889.151
Week 104n=40 Participants	165220.34	5425.379
Week 208n=31 Participants	220136.05	8168.936
Solanezumab Direct PlaceboWeek 52n=19 Participants	-9257.53	9091.376
Week 104n=14 Participants	-9263.35	9010.529
Week 208n=14 Participants	-9226.25	12358.817

Mean Difference (Final Values)229362.3095% CI199264.32 - 259460.27p<0.001t-test, 2 sided

Secondary/registry result

Solanezumab: Fluid Biomarker Measures- Total Plasma Aβ 42

Time frame:Baseline and Weeks 52, 104 and 208

concentration, descriptive

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
SolanezumabWeek 52n=34 Participants	30609.39	1555.170
Week 104n=31 Participants	29265.35	1459.112
Week 208n=24 Participants	33744.89	922.711
Solanezumab Direct PlaceboWeek 52n=15 Participants	526.91	2334.054
Week 104n=11 Participants	746.90	2424.659
Week 208n=11 Participants	838.29	1415.925

Mean Difference (Final Values)32906.6095% CI29406.49 - 36406.72p<0.001t-test, 2 sided

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Solanezumab: Fluid Biomarker Measures- Plasma Anti-drug Antibodies (ADA)

Time frame:Baseline and Weeks 52, 104 and 208

categorical status, descriptive

Secondary/registry result/low confidence

Solanezumab: Fluid Biomarker Measures- Plasma Anti-drug Antibodies (ADA)

Time frame:Baseline and Weeks 52, 104 and 208

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
SolanezumabBaseline : Not Detectedn=46 Participants	43	-
Baseline : Detectedn=46 Participants	3	-
Baseline: Detected Titer 1:10n=46 Participants	2	-
Baseline: Detected Titer 1:20n=46 Participants	1	-
Week 52 : Not Detectedn=48 Participants	44	-
Week 52 : Detectedn=48 Participants	4	-
Week 52 : Detected Titer 1:10n=48 Participants	3	-
Week 52 : Detected Titer 1:20n=48 Participants	0	-
Week 52 : Detected Titer 1:80n=48 Participants	1	-
Week 104 : Not Detectedn=43 Participants	40	-
Week 104 : Detectedn=43 Participants	3	-
Week 104 : Detected Titer 1:10n=43 Participants	0	-
Week 104 : Detected Titer 1:20n=43 Participants	1	-
Week 104 : Detected Titer 1:80n=43 Participants	1	-
Week 104 : Detected Titer 1:320n=43 Participants	1	-
Week 208 : Not Detectedn=35 Participants	33	-
Week 208 : Detectedn=35 Participants	2	-
Week 208 : Detected Titer 1:10n=35 Participants	1	-
Week 208 : Detected Titer 1:20n=35 Participants	1	-
Treatment Emergent ADA Positiven=46 Participants	2	-
>=1 Positive Neutralizing Antibody Resultn=46 Participants	0	-
Treatment Emergent ADA Inconclusiven=46 Participants	0	-
Treatment Emergent ADA Negativen=46 Participants	44	-
Mutation Positive PlacebosBaseline : Not Detectedn=25 Participants	22	-
Baseline : Detectedn=25 Participants	3	-
Baseline: Detected Titer 1:10n=25 Participants	3	-
Baseline: Detected Titer 1:20n=25 Participants	0	-
Week 52 : Not Detectedn=35 Participants	32	-
Week 52 : Detectedn=35 Participants	3	-
Week 52 : Detected Titer 1:10n=35 Participants	2	-
Week 52 : Detected Titer 1:20n=35 Participants	1	-
Week 52 : Detected Titer 1:80n=35 Participants	0	-
Week 104 : Not Detectedn=32 Participants	29	-
Week 104 : Detectedn=32 Participants	3	-
Week 104 : Detected Titer 1:10n=32 Participants	2	-
Week 104 : Detected Titer 1:20n=32 Participants	1	-
Week 104 : Detected Titer 1:80n=32 Participants	0	-
Week 104 : Detected Titer 1:320n=32 Participants	0	-
Week 208 : Not Detectedn=26 Participants	24	-
Week 208 : Detectedn=26 Participants	2	-
Week 208 : Detected Titer 1:10n=26 Participants	1	-
Week 208 : Detected Titer 1:20n=26 Participants	1	-
Treatment Emergent ADA Positiven=25 Participants	0	-
>=1 Positive Neutralizing Antibody Resultn=25 Participants	0	-
Treatment Emergent ADA Inconclusiven=25 Participants	0	-
Treatment Emergent ADA Negativen=25 Participants	25	-

Publications (13)

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

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.