← Trials/Trial dossier/NCT01193608

CompletedPhase 1Results posted

Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of Aab-003 (Pf-05236812) In Subjects With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

AAB-003 (PF-05236812)

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26•MRI contraindications excluded

Primary endpoints

•Treatment-Emergent Adverse Events (TEAEs)•Laboratory Abnormalities•Vital Signs of Potential Clinical Concern

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

Secondary ID3245K1-1000Alias Study Number

Org study IDB2601001

NCT IDNCT01193608

Timeline

Milestones

Study start2010-09 (month precision)

Study first posted2010-09-02estimated

Primary completion2013-10actual (month precision)

Study completion2013-10actual (month precision)

Last update posted2017-02-23actual

Results first posted2017-02-23actual

Assets

Drug assets

AAB-003 (PF-05236812)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease

•Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

•Caregiver will participate and be able to attend clinic visits with patient

Exclusion criteria

•Significant neurological disease other than Alzheimer's Disease

•Major psychiatric disorder

•Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)

•Women of childbearing potential

Endpoints (92)

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

Other (unclassified)

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

Fluid / digital biomarkers

Behavior / neuropsychiatric

Tau biomarkers

Neuroimaging

Executive function / language

Function / daily living

Global cognition

6 endpoints

Other/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39

Time frame:Baseline, Weeks 26 and 39

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

change from baseline, improvement

Other/protocol endpoint

Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39

Time frame:Baseline, Weeks 13, 26 and 39

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
AAB-003 0.5 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	12.6	3.73
Week 13 (n=6,5,15,15,22,19)n=6 Participants	1.3	1.45
Week 26 (n=6,5,14,13,18,19)n=6 Participants	0.9	2.73
Week 39 (n=6,4,14,13,19,17)n=6 Participants	0.2	3.13
AAB-003 1 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	20.4	7.49
Week 13 (n=6,5,15,15,22,19)n=6 Participants	3.3	4.39
Week 26 (n=6,5,14,13,18,19)n=6 Participants	0.7	4.73
Week 39 (n=6,4,14,13,19,17)n=6 Participants	1.4	3.41
AAB-003 2 mg/kgBaseline (n=6,6,16,17,24,19)n=16 Participants	21.6	10.76
Week 13 (n=6,5,15,15,22,19)n=16 Participants	-0.4	5.08
Week 26 (n=6,5,14,13,18,19)n=16 Participants	0.5	5.40
Week 39 (n=6,4,14,13,19,17)n=16 Participants	2.6	6.80
AAB-003 4 mg/kgBaseline (n=6,6,16,17,24,19)n=17 Participants	23.0	11.15
Week 13 (n=6,5,15,15,22,19)n=17 Participants	3.2	4.18
Week 26 (n=6,5,14,13,18,19)n=17 Participants	3.3	5.55
Week 39 (n=6,4,14,13,19,17)n=17 Participants	4.1	9.80
AAB-003 8 mg/kgBaseline (n=6,6,16,17,24,19)n=24 Participants	18.0	7.28
Week 13 (n=6,5,15,15,22,19)n=24 Participants	-1.2	4.20
Week 26 (n=6,5,14,13,18,19)n=24 Participants	-0.8	5.07
Week 39 (n=6,4,14,13,19,17)n=24 Participants	-0.5	5.88
PlaceboBaseline (n=6,6,16,17,24,19)n=19 Participants	18.4	7.54
Week 13 (n=6,5,15,15,22,19)n=19 Participants	0.2	3.40
Week 26 (n=6,5,14,13,18,19)n=19 Participants	1.4	5.85
Week 39 (n=6,4,14,13,19,17)n=19 Participants	1.4	3.95

Other_pre_specified/registry result

Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39

Time frame:Baseline, Weeks 26 and 39

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

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
AAB-003 0.5 mg/kgCDS-SB - Baseline (n=6,6,16,17,24,19)n=6 Participants	8.00	1.673
Global CDR - Baseline (n=6,6,16,17,24,19)n=6 Participants	0.67	0.258
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=6 Participants	1.33	1.751
Global CDR - Week 26 (n=6,5,14,14,18,19)n=6 Participants	0.33	0.408
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=6 Participants	1.00	3.286
Global CDR - Week 39 (n=6,4,14,14,19,17)n=6 Participants	0.33	0.408
AAB-003 1 mg/kgCDS-SB - Baseline (n=6,6,16,17,24,19)n=6 Participants	11.17	4.070
Global CDR - Baseline (n=6,6,16,17,24,19)n=6 Participants	1.08	0.492
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=6 Participants	1.40	1.517
Global CDR - Week 26 (n=6,5,14,14,18,19)n=6 Participants	0.30	0.447
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=6 Participants	1.75	1.708
Global CDR - Week 39 (n=6,4,14,14,19,17)n=6 Participants	0.13	0.250
AAB-003 2 mg/kgCDS-SB - Baseline (n=6,6,16,17,24,19)n=16 Participants	9.50	4.351
Global CDR - Baseline (n=6,6,16,17,24,19)n=16 Participants	1.03	0.618
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=16 Participants	-0.07	2.056
Global CDR - Week 26 (n=6,5,14,14,18,19)n=16 Participants	0.04	0.414
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=16 Participants	1.00	2.449
Global CDR - Week 39 (n=6,4,14,14,19,17)n=16 Participants	0.04	0.414
AAB-003 4 mg/kgCDS-SB - Baseline (n=6,6,16,17,24,19)n=17 Participants	10.94	3.614
Global CDR - Baseline (n=6,6,16,17,24,19)n=17 Participants	1.09	0.476
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=17 Participants	1.29	2.758
Global CDR - Week 26 (n=6,5,14,14,18,19)n=17 Participants	0.25	0.510
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=17 Participants	1.86	3.371
Global CDR - Week 39 (n=6,4,14,14,19,17)n=17 Participants	0.50	0.679
AAB-003 8 mg/kgCDS-SB - Baseline (n=6,6,16,17,24,19)n=24 Participants	8.75	3.566
Global CDR - Baseline (n=6,6,16,17,24,19)n=24 Participants	0.85	0.429
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=24 Participants	0.17	1.855
Global CDR - Week 26 (n=6,5,14,14,18,19)n=24 Participants	0.03	0.320
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=24 Participants	0.79	2.840
Global CDR - Week 39 (n=6,4,14,14,19,17)n=24 Participants	0.13	0.436
PlaceboCDS-SB - Baseline (n=6,6,16,17,24,19)n=19 Participants	8.89	3.381
Global CDR - Baseline (n=6,6,16,17,24,19)n=19 Participants	0.87	0.467
CDR-SB - Week 26 (n=6,5,14,14,18,19)n=19 Participants	0.16	1.979
Global CDR - Week 26 (n=6,5,14,14,18,19)n=19 Participants	-0.03	0.262
CDR-SB - Week 39 (n=6,4,14,14,19,17)n=19 Participants	-0.35	1.935
Global CDR - Week 39 (n=6,4,14,14,19,17)n=19 Participants	-0.06	0.300

Other_pre_specified/registry result

Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39

Time frame:Baseline, Weeks 13, 26 and 39

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
AAB-003 0.5 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	22.7	1.37
Week 13 (n=6,6,15,16,22,19)n=6 Participants	1.8	2.32
Week 26 (n=6,5,14,14,18,19)n=6 Participants	1.8	1.72
Week 39 (n=6,4,14,14,19,17)n=6 Participants	1.5	4.18
AAB-003 1 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	22.5	2.43
Week 13 (n=6,6,15,16,22,19)n=6 Participants	-0.5	2.35
Week 26 (n=6,5,14,14,18,19)n=6 Participants	0.2	1.10
Week 39 (n=6,4,14,14,19,17)n=6 Participants	-1.0	0.82
AAB-003 2 mg/kgBaseline (n=6,6,16,17,24,19)n=16 Participants	20.8	3.71
Week 13 (n=6,6,15,16,22,19)n=16 Participants	0.1	2.45
Week 26 (n=6,5,14,14,18,19)n=16 Participants	0.0	3.51
Week 39 (n=6,4,14,14,19,17)n=16 Participants	-0.2	2.58
AAB-003 4 mg/kgBaseline (n=6,6,16,17,24,19)n=17 Participants	20.1	3.00
Week 13 (n=6,6,15,16,22,19)n=17 Participants	-1.4	2.78
Week 26 (n=6,5,14,14,18,19)n=17 Participants	-2.0	2.96
Week 39 (n=6,4,14,14,19,17)n=17 Participants	-2.2	4.56
AAB-003 8 mg/kgBaseline (n=6,6,16,17,24,19)n=24 Participants	21.2	2.82
Week 13 (n=6,6,15,16,22,19)n=24 Participants	0.9	2.00
Week 26 (n=6,5,14,14,18,19)n=24 Participants	1.6	2.91
Week 39 (n=6,4,14,14,19,17)n=24 Participants	1.4	3.55
PlaceboBaseline (n=6,6,16,17,24,19)n=19 Participants	21.2	3.78
Week 13 (n=6,6,15,16,22,19)n=19 Participants	1.0	1.60
Week 26 (n=6,5,14,14,18,19)n=19 Participants	0.7	2.91
Week 39 (n=6,4,14,14,19,17)n=19 Participants	0.5	3.06

Executive function / language

2 endpoints

Primary/protocol endpoint

Number of Participants With Abnormal Neurological Examination Findings

Time frame:Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal

event count, event

Primary/registry result

Number of Participants With Abnormal Neurological Examination Findings

Time frame:Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	1	-
Week 1 (n=6,6,16,17,24,19)n=6 Participants	1	-
Week 6 (n=6,6,16,17,24,19)n=6 Participants	1	-
Week 13 (n=6,6,15,16,22,19)n=6 Participants	1	-
Week 19 (n=6,5,14,15,21,19)n=6 Participants	1	-
Week 26 (n=6,5,14,14,18,19)n=6 Participants	2	-
Week 32 (n=6,5,14,14,19,18)n=6 Participants	1	-
Week 39 (n=6,4,14,14,19,17)n=6 Participants	1	-
AAB-003 1 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	2	-
Week 1 (n=6,6,16,17,24,19)n=6 Participants	1	-
Week 6 (n=6,6,16,17,24,19)n=6 Participants	1	-
Week 13 (n=6,6,15,16,22,19)n=6 Participants	1	-
Week 19 (n=6,5,14,15,21,19)n=6 Participants	1	-
Week 26 (n=6,5,14,14,18,19)n=6 Participants	1	-
Week 32 (n=6,5,14,14,19,18)n=6 Participants	1	-
Week 39 (n=6,4,14,14,19,17)n=6 Participants	1	-
AAB-003 2 mg/kgDay 1 (n=6,6,16,17,24,19)n=16 Participants	2	-
Week 1 (n=6,6,16,17,24,19)n=16 Participants	2	-
Week 6 (n=6,6,16,17,24,19)n=16 Participants	2	-
Week 13 (n=6,6,15,16,22,19)n=16 Participants	4	-
Week 19 (n=6,5,14,15,21,19)n=16 Participants	1	-
Week 26 (n=6,5,14,14,18,19)n=16 Participants	1	-
Week 32 (n=6,5,14,14,19,18)n=16 Participants	1	-
Week 39 (n=6,4,14,14,19,17)n=16 Participants	1	-
AAB-003 4 mg/kgDay 1 (n=6,6,16,17,24,19)n=17 Participants	3	-
Week 1 (n=6,6,16,17,24,19)n=17 Participants	3	-
Week 6 (n=6,6,16,17,24,19)n=17 Participants	3	-
Week 13 (n=6,6,15,16,22,19)n=17 Participants	3	-
Week 19 (n=6,5,14,15,21,19)n=17 Participants	4	-
Week 26 (n=6,5,14,14,18,19)n=17 Participants	2	-
Week 32 (n=6,5,14,14,19,18)n=17 Participants	2	-
Week 39 (n=6,4,14,14,19,17)n=17 Participants	4	-
AAB-003 8 mg/kgDay 1 (n=6,6,16,17,24,19)n=24 Participants	1	-
Week 1 (n=6,6,16,17,24,19)n=24 Participants	0	-
Week 6 (n=6,6,16,17,24,19)n=24 Participants	0	-
Week 13 (n=6,6,15,16,22,19)n=24 Participants	0	-
Week 19 (n=6,5,14,15,21,19)n=24 Participants	1	-
Week 26 (n=6,5,14,14,18,19)n=24 Participants	1	-
Week 32 (n=6,5,14,14,19,18)n=24 Participants	0	-
Week 39 (n=6,4,14,14,19,17)n=24 Participants	0	-
PlaceboDay 1 (n=6,6,16,17,24,19)n=19 Participants	6	-
Week 1 (n=6,6,16,17,24,19)n=19 Participants	5	-
Week 6 (n=6,6,16,17,24,19)n=19 Participants	5	-
Week 13 (n=6,6,15,16,22,19)n=19 Participants	4	-
Week 19 (n=6,5,14,15,21,19)n=19 Participants	4	-
Week 26 (n=6,5,14,14,18,19)n=19 Participants	7	-
Week 32 (n=6,5,14,14,19,18)n=19 Participants	6	-
Week 39 (n=6,4,14,14,19,17)n=19 Participants	6	-

Function / daily living

2 endpoints

Other/protocol endpoint

Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
AAB-003 0.5 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	84.5	11.27
Week 13 (n=6,6,15,16,22,19)n=6 Participants	5.7	8.82
Week 26 (n=6,5,14,14,18,19)n=6 Participants	4.3	9.20
Week 39 (n=6,4,14,14,19,17)n=6 Participants	-1.8	8.40
AAB-003 1 mg/kgBaseline (n=6,6,16,17,24,19)n=6 Participants	63.7	31.89
Week 13 (n=6,6,15,16,22,19)n=6 Participants	-1.2	14.22
Week 26 (n=6,5,14,14,18,19)n=6 Participants	-0.8	12.30
Week 39 (n=6,4,14,14,19,17)n=6 Participants	0.5	12.92
AAB-003 2 mg/kgBaseline (n=6,6,16,17,24,19)n=16 Participants	78.6	20.84
Week 13 (n=6,6,15,16,22,19)n=16 Participants	-3.8	11.61
Week 26 (n=6,5,14,14,18,19)n=16 Participants	-3.8	10.20
Week 39 (n=6,4,14,14,19,17)n=16 Participants	-6.9	11.33
AAB-003 4 mg/kgBaseline (n=6,6,16,17,24,19)n=17 Participants	77.9	17.91
Week 13 (n=6,6,15,16,22,19)n=17 Participants	-5.1	15.57
Week 26 (n=6,5,14,14,18,19)n=17 Participants	-10.4	14.93
Week 39 (n=6,4,14,14,19,17)n=17 Participants	-14.6	19.52
AAB-003 8 mg/kgBaseline (n=6,6,16,17,24,19)n=24 Participants	84.8	15.31
Week 13 (n=6,6,15,16,22,19)n=24 Participants	-6.3	12.71
Week 26 (n=6,5,14,14,18,19)n=24 Participants	0.2	14.32
Week 39 (n=6,4,14,14,19,17)n=24 Participants	-1.9	12.39
PlaceboBaseline (n=6,6,16,17,24,19)n=19 Participants	84.9	12.65
Week 13 (n=6,6,15,16,22,19)n=19 Participants	-3.0	7.56
Week 26 (n=6,5,14,14,18,19)n=19 Participants	-2.5	7.73
Week 39 (n=6,4,14,14,19,17)n=19 Participants	-1.8	11.31

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 39 or Early Withdrawal

event count, event

Primary/registry result

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 39 or Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgn=6 Participants	0	-
AAB-003 1 mg/kgn=6 Participants	0	-
AAB-003 2 mg/kgn=16 Participants	1	-
AAB-003 4 mg/kgn=17 Participants	0	-
AAB-003 8 mg/kgn=24 Participants	1	-
Placebon=19 Participants	2	-

Other/protocol endpoint

Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39

Time frame:Baseline, Weeks 13, 26 and 39

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
AAB-003 0.5 mg/kgBaseline (n=6,6,16,17,23,19)n=6 Participants	11.7	9.67
Week 13 (n=6,6,15,15,21,18)n=6 Participants	-2.7	4.80
Week 26 (n=6,5,14,14,18,19)n=6 Participants	-1.7	5.24
Week 39 (n=6,3,14,13,19,17)n=6 Participants	0.5	5.21
AAB-003 1 mg/kgBaseline (n=6,6,16,17,23,19)n=6 Participants	6.3	9.18
Week 13 (n=6,6,15,15,21,18)n=6 Participants	4.8	6.68
Week 26 (n=6,5,14,14,18,19)n=6 Participants	4.8	4.09
Week 39 (n=6,3,14,13,19,17)n=6 Participants	3.3	2.52
AAB-003 2 mg/kgBaseline (n=6,6,16,17,23,19)n=16 Participants	9.1	8.69
Week 13 (n=6,6,15,15,21,18)n=16 Participants	-0.7	4.27
Week 26 (n=6,5,14,14,18,19)n=16 Participants	-1.2	2.94
Week 39 (n=6,3,14,13,19,17)n=16 Participants	0.6	6.61
AAB-003 4 mg/kgBaseline (n=6,6,16,17,23,19)n=17 Participants	10.8	11.46
Week 13 (n=6,6,15,15,21,18)n=17 Participants	0.4	7.31
Week 26 (n=6,5,14,14,18,19)n=17 Participants	4.6	12.17
Week 39 (n=6,3,14,13,19,17)n=17 Participants	4.8	17.07
AAB-003 8 mg/kgBaseline (n=6,6,16,17,23,19)n=24 Participants	7.7	7.30
Week 13 (n=6,6,15,15,21,18)n=24 Participants	0.3	4.94
Week 26 (n=6,5,14,14,18,19)n=24 Participants	0.3	6.01
Week 39 (n=6,3,14,13,19,17)n=24 Participants	0.1	6.70
PlaceboBaseline (n=6,6,16,17,23,19)n=19 Participants	13.8	12.93
Week 13 (n=6,6,15,15,21,18)n=19 Participants	-2.1	6.81
Week 26 (n=6,5,14,14,18,19)n=19 Participants	-3.4	8.65
Week 39 (n=6,3,14,13,19,17)n=19 Participants	-2.6	10.63

Amyloid biomarkers

20 endpoints

Other/protocol endpoint

Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Other/protocol endpoint

CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Other/protocol endpoint

Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Other/protocol endpoint

CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Other/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

concentration, descriptive

Other/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

time to event, event

Other/protocol endpoint

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40

Time frame:Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

concentration, descriptive

Other/protocol endpoint

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40

descriptive

Other/protocol endpoint

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

descriptive

Other/protocol endpoint

Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40

concentration, descriptive

Other_pre_specified/registry result

Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Posted result

Group	Value (mean), picogram/milliliter (pg/mL)	Standard deviation
AAB-003 8 mg/kgn=15 Participants	113.53	817.270
Placebon=5 Participants	348.64	1321.047

Mean change113.5380% CI-170.30 - 397.35p0.599t-test, 2 sided

Change from baseline, within group

Other_pre_specified/registry result

CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Posted result

Group	Value (mean), picogram/milliliter (pg/mL)	Standard deviation
AAB-003 2 mg/kgBaselinen=1 Participants	5685.4	NA
Week 32n=1 Participants	5836.1	NA
AAB-003 4 mg/kgBaselinen=1 Participants	7413.6	NA
Week 32n=1 Participants	8883.2	NA

Other_pre_specified/registry result

Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 8 mg/kgn=15 Participants	48.85	174.589
Placebon=5 Participants	24.04	173.610

Mean change48.8580% CI-11.79 - 109.48p0.297t-test, 2 sided

Change from baseline, within group

Other_pre_specified/registry result

CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 2 mg/kgBaselinen=1 Participants	485.6	NA
Week 32n=1 Participants	343.3	NA
AAB-003 4 mg/kgBaselinen=1 Participants	217.2	NA
Week 32n=1 Participants	331	NA

Other_pre_specified/registry result

Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=6 Participants	3.321	50
Week 26 - Week 39 (n=5,4,14,14,17,14)n=6 Participants	1.964	35
AAB-003 1 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=6 Participants	6.959	29
Week 26 - Week 39 (n=5,4,14,14,17,14)n=6 Participants	3.805	31
AAB-003 2 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=16 Participants	8.202	19
Week 26 - Week 39 (n=5,4,14,14,17,14)n=16 Participants	3.804	23
AAB-003 4 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=17 Participants	11.89	10
Week 26 - Week 39 (n=5,4,14,14,17,14)n=17 Participants	7.537	26
AAB-003 8 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=24 Participants	18.03	19
Week 26 - Week 39 (n=5,4,14,14,17,14)n=24 Participants	12.25	20
PlaceboWeek 1 - Week 13 (n=6,5,14,16,22,19)n=19 Participants	0.3511	25
Week 26 - Week 39 (n=5,4,14,14,17,14)n=19 Participants	0.4689	84

Other_pre_specified/registry result

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

time to event, event

Posted result

Group	Value (median), Hours	Reported spread / bounds
AAB-003 0.5 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=6 Participants	24.2	5022.3 - 149
Week 26 - Week 39 (n=5,4,14,14,17,14)n=6 Participants	2.03	352.02 - 596
AAB-003 1 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=5 Participants	24.0	2924.0 - 169
Week 26 - Week 39 (n=5,4,14,14,17,14)n=5 Participants	2.00	312.00 - 2.02
AAB-003 2 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=15 Participants	24.0	1924.0 - 170
Week 26 - Week 39 (n=5,4,14,14,17,14)n=15 Participants	983	232.00 - 1080
AAB-003 4 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=16 Participants	166	1024.0 - 238
Week 26 - Week 39 (n=5,4,14,14,17,14)n=16 Participants	1010	26958 - 1060
AAB-003 8 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=22 Participants	164	1992.2 - 1050
Week 26 - Week 39 (n=5,4,14,14,17,14)n=22 Participants	1010	201.98 - 1080
PlaceboWeek 1 - Week 13 (n=6,5,14,16,22,19)n=19 Participants	168	250.000 - 2540
Week 26 - Week 39 (n=5,4,14,14,17,14)n=19 Participants	1030	840.000 - 2210

Other_pre_specified/registry result

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	Reported spread / bounds
AAB-003 0.5 mg/kgn=6 Participants	2664	3122.3 - 149
AAB-003 1 mg/kgn=5 Participants	6041	4724.0 - 169
AAB-003 2 mg/kgn=14 Participants	7836	1924.0 - 170
AAB-003 4 mg/kgn=16 Participants	12970	1724.0 - 238
AAB-003 8 mg/kgn=22 Participants	22910	2592.2 - 1050
Placebon=19 Participants	639.7	230.000 - 2540

Other_pre_specified/registry result

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40

descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=1 Participants	2916	NA
AAB-003 1 mg/kgn=1 Participants	5463	NA
AAB-003 2 mg/kgn=9 Participants	8965	19
AAB-003 4 mg/kgn=2 Participants	12800	1

Other_pre_specified/registry result

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40

Time frame:Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.

descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	Reported spread / bounds
AAB-003 0.5 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=6 Participants	2647	3122.3 - 149
Week 26 - Week 39 (n=5,4,14,14,17,14)n=6 Participants	2614	322.02 - 596
AAB-003 1 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=5 Participants	6057	4724.0 - 169
Week 26 - Week 39 (n=5,4,14,14,17,14)n=5 Participants	4929	372.00 - 2.02
AAB-003 2 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=15 Participants	7854	1924.0 - 170
Week 26 - Week 39 (n=5,4,14,14,17,14)n=15 Participants	6119	312.00 - 1080
AAB-003 4 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=16 Participants	12940	1724.0 - 238
Week 26 - Week 39 (n=5,4,14,14,17,14)n=16 Participants	11910	26958 - 1060
AAB-003 8 mg/kgWeek 1 - Week 13 (n=6,5,14,16,22,19)n=22 Participants	22820	2692.2 - 1050
Week 26 - Week 39 (n=5,4,14,14,17,14)n=22 Participants	19740	251.98 - 1080
PlaceboWeek 1 - Week 13 (n=6,5,14,16,22,19)n=19 Participants	631.6	230.000 - 2540
Week 26 - Week 39 (n=5,4,14,14,17,14)n=19 Participants	798.8	550.000 - 2210

Other_pre_specified/registry result

Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40

concentration, descriptive

Posted result

Group	Value (mean), Day	Standard deviation
AAB-003 0.5 mg/kgn=1 Participants	26.57	NA
AAB-003 1 mg/kgn=1 Participants	32.14	NA
AAB-003 2 mg/kgn=9 Participants	30.71	3.2303
AAB-003 4 mg/kgn=2 Participants	29.41	5.7374

Tau biomarkers

4 endpoints

Other/protocol endpoint

Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Other/protocol endpoint

CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Other_pre_specified/registry result

Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 8 mg/kgn=15 Participants	1.23	8.986
Placebon=5 Participants	1.92	7.755

Mean change1.2380% CI-1.89 - 4.35p0.603t-test, 2 sided

Change from baseline, within group

Other_pre_specified/registry result

CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 2 mg/kgBaselinen=1 Participants	89	NA
Week 32n=1 Participants	100.3	NA
AAB-003 4 mg/kgBaselinen=1 Participants	122.7	NA
Week 32n=1 Participants	140.5	NA

Neuroimaging

4 endpoints

Primary/protocol endpoint

Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding

Time frame:Baseline up to Week 32.

event count, event

Primary/protocol endpoint

Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit

Time frame:Day 1, Week 13, and Week 26

event count, event

Primary/registry result

Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding

Time frame:Baseline up to Week 32.

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgn=6 Participants	0	-
AAB-003 1 mg/kgn=6 Participants	0	-
AAB-003 2 mg/kgn=16 Participants	0	-
AAB-003 4 mg/kgn=17 Participants	0	-
AAB-003 8 mg/kgn=24 Participants	5	-
Placebon=19 Participants	0	-

Primary/registry result

Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit

Time frame:Day 1, Week 13, and Week 26

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	0	-
Week 13 (n=6,5,15,16,21,17)n=6 Participants	0	-
Week 26 (n=6,5,14,14,17,16)n=6 Participants	0	-
AAB-003 1 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	0	-
Week 13 (n=6,5,15,16,21,17)n=6 Participants	0	-
Week 26 (n=6,5,14,14,17,16)n=6 Participants	0	-
AAB-003 2 mg/kgDay 1 (n=6,6,16,17,24,19)n=16 Participants	0	-
Week 13 (n=6,5,15,16,21,17)n=16 Participants	0	-
Week 26 (n=6,5,14,14,17,16)n=16 Participants	0	-
AAB-003 4 mg/kgDay 1 (n=6,6,16,17,24,19)n=17 Participants	0	-
Week 13 (n=6,5,15,16,21,17)n=17 Participants	0	-
Week 26 (n=6,5,14,14,17,16)n=17 Participants	0	-
AAB-003 8 mg/kgDay 1 (n=6,6,16,17,24,19)n=24 Participants	1	-
Week 13 (n=6,5,15,16,21,17)n=24 Participants	1	-
Week 26 (n=6,5,14,14,17,16)n=24 Participants	0	-
PlaceboDay 1 (n=6,6,16,17,24,19)n=19 Participants	0	-
Week 13 (n=6,5,15,16,21,17)n=19 Participants	0	-
Week 26 (n=6,5,14,14,17,16)n=19 Participants	0	-

Fluid / digital biomarkers

6 endpoints

Other/protocol endpoint

Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32

Time frame:Week 32 or Early Withdrawal

concentration, descriptive

Other/protocol endpoint

Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Other/protocol endpoint

CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Other_pre_specified/registry result

Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32

Time frame:Week 32 or Early Withdrawal

concentration, descriptive

Posted result

Group	Value (mean), nanogram/millliter (ng/mL)	Standard deviation
AAB-003 2 mg/kgn=1 Participants	15.220	NA
AAB-003 4 mg/kgn=1 Participants	45.020	NA
AAB-003 8 mg/kgn=15 Participants	79.160	53.0486

Other_pre_specified/registry result

Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups

Time frame:Baseline and Week 32

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 8 mg/kgn=15 Participants	-15.26	110.229
Placebon=5 Participants	67.94	63.514

Mean change-15.2680% CI-53.54 - 23.02p0.600t-test, 2 sided

Change from baseline, within group

Other_pre_specified/registry result

CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups

Time frame:Baseline and Week 32

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
AAB-003 2 mg/kgBaselinen=1 Participants	659.6	NA
Week 32n=1 Participants	739.4	NA
AAB-003 4 mg/kgBaselinen=1 Participants	856.1	NA
Week 32n=1 Participants	1115.6	NA

Safety / tolerability / PK

18 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Primary/protocol endpoint

Number of Participants With Vital Signs of Potential Clinical Concern

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

change from baseline, event

Primary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Primary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

time to event, event

Primary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

time to event, event

Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgParticipants with Adverse Events (AEs)n=6 Participants	5	-
Participants with Serious Adverse Events (SAEs)n=6 Participants	1	-
Participants Discontinued due to AEsn=6 Participants	0	-
AAB-003 1 mg/kgParticipants with Adverse Events (AEs)n=6 Participants	3	-
Participants with Serious Adverse Events (SAEs)n=6 Participants	1	-
Participants Discontinued due to AEsn=6 Participants	0	-
AAB-003 2 mg/kgParticipants with Adverse Events (AEs)n=16 Participants	10	-
Participants with Serious Adverse Events (SAEs)n=16 Participants	1	-
Participants Discontinued due to AEsn=16 Participants	0	-
AAB-003 4 mg/kgParticipants with Adverse Events (AEs)n=17 Participants	8	-
Participants with Serious Adverse Events (SAEs)n=17 Participants	0	-
Participants Discontinued due to AEsn=17 Participants	0	-
AAB-003 8 mg/kgParticipants with Adverse Events (AEs)n=24 Participants	16	-
Participants with Serious Adverse Events (SAEs)n=24 Participants	5	-
Participants Discontinued due to AEsn=24 Participants	3	-
PlaceboParticipants with Adverse Events (AEs)n=19 Participants	12	-
Participants with Serious Adverse Events (SAEs)n=19 Participants	0	-
Participants Discontinued due to AEsn=19 Participants	1	-

Primary/registry result

Number of Participants With Vital Signs of Potential Clinical Concern

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

change from baseline, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgSupine SBP <90 mm Hgn=6 Participants	0	-
Maximum increase in supine SBP >=30 mm Hgn=6 Participants	3	-
Maximum decrease in supine SBP >=30 mm Hgn=6 Participants	0	-
Sitting SBP <90 mm Hgn=6 Participants	NA	-
Supine DBP <50 mm Hgn=6 Participants	0	-
Maximum increase in supine DBP >=20 mm Hgn=6 Participants	2	-
Maximum decrease in supine DBP >=20 mm Hgn=6 Participants	1	-
Sitting DBP <50 mm Hgn=6 Participants	NA	-
Supine pulse rate <40 or >120 bpmn=6 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=6 Participants	NA	-
AAB-003 1 mg/kgSupine SBP <90 mm Hgn=6 Participants	0	-
Maximum increase in supine SBP >=30 mm Hgn=6 Participants	0	-
Maximum decrease in supine SBP >=30 mm Hgn=6 Participants	0	-
Sitting SBP <90 mm Hgn=6 Participants	NA	-
Supine DBP <50 mm Hgn=6 Participants	0	-
Maximum increase in supine DBP >=20 mm Hgn=6 Participants	3	-
Maximum decrease in supine DBP >=20 mm Hgn=6 Participants	0	-
Sitting DBP <50 mm Hgn=6 Participants	NA	-
Supine pulse rate <40 or >120 bpmn=6 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=6 Participants	NA	-
AAB-003 2 mg/kgSupine SBP <90 mm Hgn=16 Participants	1	-
Maximum increase in supine SBP >=30 mm Hgn=16 Participants	3	-
Maximum decrease in supine SBP >=30 mm Hgn=16 Participants	5	-
Sitting SBP <90 mm Hgn=16 Participants	NA	-
Supine DBP <50 mm Hgn=16 Participants	0	-
Maximum increase in supine DBP >=20 mm Hgn=16 Participants	4	-
Maximum decrease in supine DBP >=20 mm Hgn=16 Participants	4	-
Sitting DBP <50 mm Hgn=16 Participants	NA	-
Supine pulse rate <40 or >120 bpmn=16 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=16 Participants	NA	-
AAB-003 4 mg/kgSupine SBP <90 mm Hgn=17 Participants	0	-
Maximum increase in supine SBP >=30 mm Hgn=17 Participants	7	-
Maximum decrease in supine SBP >=30 mm Hgn=17 Participants	0	-
Sitting SBP <90 mm Hgn=17 Participants	NA	-
Supine DBP <50 mm Hgn=17 Participants	0	-
Maximum increase in supine DBP >=20 mm Hgn=17 Participants	2	-
Maximum decrease in supine DBP >=20 mm Hgn=17 Participants	1	-
Sitting DBP <50 mm Hgn=17 Participants	NA	-
Supine pulse rate <40 or >120 bpmn=17 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=17 Participants	NA	-
AAB-003 8 mg/kgSupine SBP <90 mm Hgn=24 Participants	1	-
Maximum increase in supine SBP >=30 mm Hgn=24 Participants	2	-
Maximum decrease in supine SBP >=30 mm Hgn=24 Participants	4	-
Sitting SBP <90 mm Hgn=24 Participants	0	-
Supine DBP <50 mm Hgn=24 Participants	0	-
Maximum increase in supine DBP >=20 mm Hgn=24 Participants	5	-
Maximum decrease in supine DBP >=20 mm Hgn=24 Participants	4	-
Sitting DBP <50 mm Hgn=24 Participants	0	-
Supine pulse rate <40 or >120 bpmn=24 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=24 Participants	0	-
PlaceboSupine SBP <90 mm Hgn=19 Participants	0	-
Maximum increase in supine SBP >=30 mm Hgn=19 Participants	6	-
Maximum decrease in supine SBP >=30 mm Hgn=19 Participants	8	-
Sitting SBP <90 mm Hgn=19 Participants	0	-
Supine DBP <50 mm Hgn=19 Participants	1	-
Maximum increase in supine DBP >=20 mm Hgn=19 Participants	8	-
Maximum decrease in supine DBP >=20 mm Hgn=19 Participants	8	-
Sitting DBP <50 mm Hgn=19 Participants	0	-
Supine pulse rate <40 or >120 bpmn=19 Participants	0	-
Sitting pulse rate <40 or >120 bpmn=19 Participants	0	-

Primary/registry result

Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (geometric_mean), microgram per milliliter (mcg/mL)	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	13.79	48
AAB-003 1 mg/kgn=6 Participants	32.05	33
AAB-003 2 mg/kgn=16 Participants	58.74	21
AAB-003 4 mg/kgn=17 Participants	122.4	14
AAB-003 8 mg/kgn=24 Participants	223.7	28

Primary/protocol endpoint

Serum Decay Half-Life (t1/2) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Primary/registry result

Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (geometric_mean), mcg/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	14.53	33
AAB-003 1 mg/kgn=5 Participants	38.51	25
AAB-003 2 mg/kgn=14 Participants	60.17	38
AAB-003 4 mg/kgn=14 Participants	108.5	41
AAB-003 8 mg/kgn=17 Participants	228.9	30

Primary/protocol endpoint

Serum Decay Half-Life (t1/2) for AAB-003 at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Primary/registry result

Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

time to event, event

Posted result

Group	Value (median), Hours (hr)	Reported spread / bounds
AAB-003 0.5 mg/kgn=6 Participants	1.92	301.50 - 6.05
AAB-003 1 mg/kgn=6 Participants	4.00	332.17 - 6.02
AAB-003 2 mg/kgn=16 Participants	1.54	161.20 - 2.12
AAB-003 4 mg/kgn=17 Participants	1.50	201.00 - 24.0
AAB-003 8 mg/kgn=24 Participants	3.02	241.07 - 6.00

Primary/registry result

Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

time to event, event

Posted result

Group	Value (median), Hours (hr)	Reported spread / bounds
AAB-003 0.5 mg/kgn=6 Participants	1.56	221.30 - 4.05
AAB-003 1 mg/kgn=5 Participants	2.00	91.25 - 5.95
AAB-003 2 mg/kgn=14 Participants	1.64	281.05 - 6.03
AAB-003 4 mg/kgn=14 Participants	2.00	291.03 - 6.03
AAB-003 8 mg/kgn=17 Participants	1.50	341.07 - 23.9

Primary/protocol endpoint

Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria

Time frame:Baseline, Weeks 1,13,16,26,39 or Early Withdrawal

change from baseline, event

Primary/registry result

Serum Decay Half-Life (t1/2) for AAB-003 at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (mean), Days	Standard deviation
AAB-003 0.5 mg/kgn=4 Participants	27.77	6.9880
AAB-003 1 mg/kgn=3 Participants	20.04	8.9210
AAB-003 2 mg/kgn=14 Participants	24.45	4.8686
AAB-003 4 mg/kgn=14 Participants	21.10	5.2000
AAB-003 8 mg/kgn=19 Participants	22.89	4.5086

Primary/registry result

Serum Decay Half-Life (t1/2) for AAB-003 at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (mean), Days	Standard deviation
AAB-003 0.5 mg/kgn=5 Participants	23.41	6.8638
AAB-003 1 mg/kgn=4 Participants	22.32	3.1454
AAB-003 2 mg/kgn=13 Participants	22.83	4.1356
AAB-003 4 mg/kgn=11 Participants	22.27	3.2448
AAB-003 8 mg/kgn=16 Participants	22.81	4.3455

Primary/registry result

Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria

Time frame:Baseline, Weeks 1,13,16,26,39 or Early Withdrawal

change from baseline, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgMaximum PR Interval >=300 msecn=6 Participants	0	-
Maximum QRS Complex >=200 msecn=6 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=6 Participants	0	-
Maximum QTcF Interval 480 to <500 msecn=6 Participants	0	-
Maximum QTcF Interval >=500 msecn=6 Participants	0	-
PR Interval >=25/50% increasen=6 Participants	0	-
QRS Complex >=25/50% increasen=6 Participants	0	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=6 Participants	2	-
Maximum QTcF Interval Increase >=60 msecn=6 Participants	0	-
AAB-003 1 mg/kgMaximum PR Interval >=300 msecn=6 Participants	0	-
Maximum QRS Complex >=200 msecn=6 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=6 Participants	2	-
Maximum QTcF Interval 480 to <500 msecn=6 Participants	0	-
Maximum QTcF Interval >=500 msecn=6 Participants	0	-
PR Interval >=25/50% increasen=6 Participants	0	-
QRS Complex >=25/50% increasen=6 Participants	0	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=6 Participants	1	-
Maximum QTcF Interval Increase >=60 msecn=6 Participants	0	-
AAB-003 2 mg/kgMaximum PR Interval >=300 msecn=16 Participants	0	-
Maximum QRS Complex >=200 msecn=16 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=16 Participants	5	-
Maximum QTcF Interval 480 to <500 msecn=16 Participants	1	-
Maximum QTcF Interval >=500 msecn=16 Participants	0	-
PR Interval >=25/50% increasen=16 Participants	0	-
QRS Complex >=25/50% increasen=16 Participants	0	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=16 Participants	2	-
Maximum QTcF Interval Increase >=60 msecn=16 Participants	0	-
AAB-003 4 mg/kgMaximum PR Interval >=300 msecn=17 Participants	0	-
Maximum QRS Complex >=200 msecn=17 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=17 Participants	4	-
Maximum QTcF Interval 480 to <500 msecn=17 Participants	0	-
Maximum QTcF Interval >=500 msecn=17 Participants	0	-
PR Interval >=25/50% increasen=17 Participants	0	-
QRS Complex >=25/50% increasen=17 Participants	0	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=17 Participants	1	-
Maximum QTcF Interval Increase >=60 msecn=17 Participants	0	-
AAB-003 8 mg/kgMaximum PR Interval >=300 msecn=24 Participants	0	-
Maximum QRS Complex >=200 msecn=24 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=24 Participants	4	-
Maximum QTcF Interval 480 to <500 msecn=24 Participants	1	-
Maximum QTcF Interval >=500 msecn=24 Participants	0	-
PR Interval >=25/50% increasen=24 Participants	0	-
QRS Complex >=25/50% increasen=24 Participants	0	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=24 Participants	2	-
Maximum QTcF Interval Increase >=60 msecn=24 Participants	0	-
PlaceboMaximum PR Interval >=300 msecn=19 Participants	0	-
Maximum QRS Complex >=200 msecn=19 Participants	0	-
Maximum QTcF Interval 450 to <480 msecn=19 Participants	3	-
Maximum QTcF Interval 480 to <500 msecn=19 Participants	0	-
Maximum QTcF Interval >=500 msecn=19 Participants	0	-
PR Interval >=25/50% increasen=19 Participants	0	-
QRS Complex >=25/50% increasen=19 Participants	1	-
Maximum QTcF Increase from Baseline 30 to <60 msecn=19 Participants	3	-
Maximum QTcF Interval Increase >=60 msecn=19 Participants	0	-

Other (unclassified)

26 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Laboratory Abnormalities

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Abnormal Physical Examination Findings

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Primary/protocol endpoint/low confidence

Average Concentration (Cavg) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Primary/protocol endpoint/low confidence

Average Concentration (Cavg) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Primary/protocol endpoint/low confidence

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Primary/protocol endpoint/low confidence

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Primary/protocol endpoint/low confidence

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Primary/protocol endpoint/low confidence

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Primary/registry result/low confidence

Number of Participants With Laboratory Abnormalities

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgn=6 Participants	3	-
AAB-003 1 mg/kgn=6 Participants	3	-
AAB-003 2 mg/kgn=16 Participants	11	-
AAB-003 4 mg/kgn=17 Participants	10	-
AAB-003 8 mg/kgn=24 Participants	12	-
Placebon=19 Participants	13	-

Primary/protocol endpoint/low confidence

Systemic Clearance (CL) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Primary/protocol endpoint/low confidence

Systemic Clearance (CL) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Primary/registry result/low confidence

Number of Participants With Abnormal Physical Examination Findings

Time frame:Baseline up to 39 Weeks and at Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgn=6 Participants	2	-
AAB-003 1 mg/kgn=6 Participants	4	-
AAB-003 2 mg/kgn=16 Participants	1	-
AAB-003 4 mg/kgn=17 Participants	5	-
AAB-003 8 mg/kgn=24 Participants	9	-
Placebon=19 Participants	9	-

Primary/protocol endpoint/low confidence

Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Primary/protocol endpoint/low confidence

Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Primary/registry result/low confidence

Average Concentration (Cavg) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (geometric_mean), mcg/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	2.465	30
AAB-003 1 mg/kgn=5 Participants	6.545	33
AAB-003 2 mg/kgn=15 Participants	10.83	16
AAB-003 4 mg/kgn=16 Participants	20.37	20
AAB-003 8 mg/kgn=22 Participants	36.78	24

Primary/registry result/low confidence

Average Concentration (Cavg) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (geometric_mean), mcg/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	3.435	22
AAB-003 1 mg/kgn=4 Participants	7.171	9
AAB-003 2 mg/kgn=14 Participants	12.56	28
AAB-003 4 mg/kgn=14 Participants	22.52	29
AAB-003 8 mg/kgn=17 Participants	46.12	34

Primary/registry result/low confidence

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

concentration, descriptive

Posted result

Group	Value (geometric_mean), mcg*hr/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	5397	30
AAB-003 1 mg/kgn=6 Participants	13470	33
AAB-003 2 mg/kgn=16 Participants	22960	19
AAB-003 4 mg/kgn=17 Participants	44000	20
AAB-003 8 mg/kgn=24 Participants	79130	23

Primary/registry result/low confidence

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mcg*hr/mL	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=4 Participants	5597	39
AAB-003 1 mg/kgn=3 Participants	13060	18
AAB-003 2 mg/kgn=14 Participants	25270	17
AAB-003 4 mg/kgn=14 Participants	46430	21
AAB-003 8 mg/kgn=19 Participants	82140	23

Primary/registry result/low confidence

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mcg*hr/mL	Reported spread / bounds
AAB-003 0.5 mg/kgn=6 Participants	5384	301.50 - 6.05
AAB-003 1 mg/kgn=5 Participants	14300	332.17 - 6.02
AAB-003 2 mg/kgn=15 Participants	23660	161.20 - 2.12
AAB-003 4 mg/kgn=16 Participants	44490	201.00 - 24.0
AAB-003 8 mg/kgn=22 Participants	80320	241.07 - 6.00

Primary/registry result/low confidence

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mcg*hr/mL	Reported spread / bounds
AAB-003 0.5 mg/kgn=6 Participants	7502	221.30 - 4.05
AAB-003 1 mg/kgn=4 Participants	15660	91.25 - 5.95
AAB-003 2 mg/kgn=14 Participants	27440	281.05 - 6.03
AAB-003 4 mg/kgn=14 Participants	49180	291.03 - 6.03
AAB-003 8 mg/kgn=17 Participants	100700	341.07 - 23.9

Primary/registry result/low confidence

Systemic Clearance (CL) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), milliliter/hour/kilogram (mL/hr/kg)	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=4 Participants	0.08934	39
AAB-003 1 mg/kgn=3 Participants	0.07657	18
AAB-003 2 mg/kgn=14 Participants	0.07914	17
AAB-003 4 mg/kgn=14 Participants	0.08615	21
AAB-003 8 mg/kgn=19 Participants	0.09739	23

Primary/registry result/low confidence

Systemic Clearance (CL) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mL/hr/kg	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=6 Participants	0.06665	22
AAB-003 1 mg/kgn=4 Participants	0.06385	9
AAB-003 2 mg/kgn=14 Participants	0.07289	28
AAB-003 4 mg/kgn=14 Participants	0.08133	29
AAB-003 8 mg/kgn=17 Participants	0.07943	34

Primary/registry result/low confidence

Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mL/kg	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=4 Participants	78.44	38
AAB-003 1 mg/kgn=3 Participants	59.74	37
AAB-003 2 mg/kgn=14 Participants	61.67	21
AAB-003 4 mg/kgn=14 Participants	60.44	26
AAB-003 8 mg/kgn=19 Participants	75.12	27

Primary/registry result/low confidence

Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26

Time frame:Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.

descriptive

Posted result

Group	Value (geometric_mean), mL/kg	Geometric coefficient of variation
AAB-003 0.5 mg/kgn=5 Participants	54.66	18
AAB-003 1 mg/kgn=4 Participants	48.27	9
AAB-003 2 mg/kgn=13 Participants	56.90	37
AAB-003 4 mg/kgn=11 Participants	65.11	23
AAB-003 8 mg/kgn=16 Participants	61.24	46

Other/protocol endpoint/low confidence

Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum

Time frame:Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal

event count, event

Other_pre_specified/registry result/low confidence

Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum

Time frame:Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
AAB-003 0.5 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=6 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=6 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=6 Participants	0	-
AAB-003 1 mg/kgDay 1 (n=6,6,16,17,24,19)n=6 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=6 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=6 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=6 Participants	0	-
AAB-003 2 mg/kgDay 1 (n=6,6,16,17,24,19)n=16 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=16 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=16 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=16 Participants	0	-
AAB-003 4 mg/kgDay 1 (n=6,6,16,17,24,19)n=17 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=17 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=17 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=17 Participants	0	-
AAB-003 8 mg/kgDay 1 (n=6,6,16,17,24,19)n=24 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=24 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=24 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=24 Participants	0	-
PlaceboDay 1 (n=6,6,16,17,24,19)n=19 Participants	0	-
Week 13 (n=6,5,15,16,22,19)n=19 Participants	0	-
Week 26 (n=6,5,14,14,17,18)n=19 Participants	0	-
Week 39 (n=6,4,14,14,19,16)n=19 Participants	0	-

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

Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
PMID26925577via 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.