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CompletedPhase 1Results posted

Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001

Lead sponsor

Pfizer

Asset

AAB-003 (PF-05236812)

Listed sites

21

Recruiting sites

-

Enrollment

52

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 50-90•Brain MRI excludes vasogenic edema

Primary endpoints

•Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)•Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern•Potentially Clinically Important Vital Sign Findings

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 IDB2601003
NCT IDNCT01369225

Timeline

Milestones

Study first posted2011-06-08estimated
Study start2011-07 (month precision)
Primary completion2014-08actual (month precision)
Study completion2014-08actual (month precision)
Last update posted2017-03-10actual
Results first posted2017-03-10actual

Assets

Drug assets

AAB-003 (PF-05236812)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Successful completion of study B2601001
•MMSE 12 or greater

Exclusion criteria

•Study B2601001 Week 32 MRI with clinically important exclusionary findings.
•Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001

Endpoints (28)

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
6
Safety / tolerability / PK
6
Other (unclassified)
6
Behavior / neuropsychiatric
4
Executive function / language
2
Function / daily living
2
Neuroimaging
2

Global cognition

6 endpoints
Other/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52

Time frame:Baseline, Week 52

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

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52

Time frame:Baseline, Week 52

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) Scores at Week 52

Time frame:Baseline, Week 52

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,12,9)n=6 Participants12.04.58
Change at Week 52 (n=4,3,9,8,10,8)n=6 Participants3.73.98
AAB-003 1 mg/kgBaseline (n=6,3,12,10,12,9)n=3 Participants22.711.79
Change at Week 52 (n=4,3,9,8,10,8)n=3 Participants3.07.22
AAB-003 2 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants25.114.11
Change at Week 52 (n=4,3,9,8,10,8)n=12 Participants5.54.30
AAB-003 4 mg/kgBaseline (n=6,3,12,10,12,9)n=10 Participants23.89.21
Change at Week 52 (n=4,3,9,8,10,8)n=10 Participants2.84.56
AAB-003 8 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants19.610.72
Change at Week 52 (n=4,3,9,8,10,8)n=12 Participants5.94.22
Placebo/AAB-003Baseline (n=6,3,12,10,12,9)n=9 Participants23.311.00
Change at Week 52 (n=4,3,9,8,10,8)n=9 Participants2.56.07
Other_pre_specified/registry result

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52

Time frame:Baseline, Week 52

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

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,12,9)n=6 Participants9.003.347
Change at Week 52 (n=4,3,9,8,10,9)n=6 Participants0.000.816
AAB-003 1 mg/kgBaseline (n=6,3,12,10,12,9)n=3 Participants11.001.000
Change at Week 52 (n=4,3,9,8,10,9)n=3 Participants0.330.577
AAB-003 2 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants11.335.710
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants2.672.291
AAB-003 4 mg/kgBaseline (n=6,3,12,10,12,9)n=10 Participants10.304.473
Change at Week 52 (n=4,3,9,8,10,9)n=10 Participants2.381.598
AAB-003 8 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants10.334.313
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants1.102.378
Placebo/AAB-003Baseline (n=6,3,12,10,12,9)n=9 Participants9.563.941
Change at Week 52 (n=4,3,9,8,10,9)n=9 Participants2.562.789
Other_pre_specified/registry result

Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52

Time frame:Baseline, Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,12,9)n=6 Participants24.71.86
Change at Week 52 (n=4,3,9,8,10,9)n=6 Participants-1.02.94
AAB-003 1 mg/kgBaseline (n=6,3,12,10,12,9)n=3 Participants21.04.36
Change at Week 52 (n=4,3,9,8,10,9)n=3 Participants1.71.15
AAB-003 2 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants19.35.05
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants-2.72.78
AAB-003 4 mg/kgBaseline (n=6,3,12,10,12,9)n=10 Participants18.54.86
Change at Week 52 (n=4,3,9,8,10,9)n=10 Participants-2.11.64
AAB-003 8 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants21.35.40
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants-2.02.16
Placebo/AAB-003Baseline (n=6,3,12,10,12,9)n=9 Participants18.95.64
Change at Week 52 (n=4,3,9,8,10,9)n=9 Participants-1.73.91

Executive function / language

2 endpoints
Primary/protocol endpoint

Number of Participants With Abnormal Neurological Examination Findings

Time frame:Baseline up to Week 52

event count, event

Primary/registry result

Number of Participants With Abnormal Neurological Examination Findings

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgCranial Nerve Functionn=6 Participants1-
Coordinationn=6 Participants0-
Deep Tendon Reflexesn=6 Participants0-
Motor Functionn=6 Participants0-
Gait and Stationn=6 Participants0-
AAB-003 1 mg/kgCranial Nerve Functionn=3 Participants0-
Coordinationn=3 Participants0-
Deep Tendon Reflexesn=3 Participants0-
Motor Functionn=3 Participants1-
Gait and Stationn=3 Participants1-
AAB-003 2 mg/kgCranial Nerve Functionn=12 Participants0-
Coordinationn=12 Participants0-
Deep Tendon Reflexesn=12 Participants1-
Motor Functionn=12 Participants0-
Gait and Stationn=12 Participants0-
AAB-003 4 mg/kgCranial Nerve Functionn=10 Participants2-
Coordinationn=10 Participants1-
Deep Tendon Reflexesn=10 Participants0-
Motor Functionn=10 Participants0-
Gait and Stationn=10 Participants0-
AAB-003 8 mg/kgCranial Nerve Functionn=12 Participants0-
Coordinationn=12 Participants0-
Deep Tendon Reflexesn=12 Participants0-
Motor Functionn=12 Participants0-
Gait and Stationn=12 Participants0-
Placebo/AAB-003Cranial Nerve Functionn=9 Participants0-
Coordinationn=9 Participants1-
Deep Tendon Reflexesn=9 Participants0-
Motor Functionn=9 Participants1-
Gait and Stationn=9 Participants1-

Function / daily living

2 endpoints
Other/protocol endpoint

Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,12,9)n=6 Participants83.712.50
Change at Week 52 (n=4,3,9,8,10,9)n=6 Participants-5.024.75
AAB-003 1 mg/kgBaseline (n=6,3,12,10,12,9)n=3 Participants73.37.64
Change at Week 52 (n=4,3,9,8,10,9)n=3 Participants-9.76.43
AAB-003 2 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants69.523.82
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants-10.415.26
AAB-003 4 mg/kgBaseline (n=6,3,12,10,12,9)n=10 Participants72.427.11
Change at Week 52 (n=4,3,9,8,10,9)n=10 Participants-7.56.72
AAB-003 8 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants78.319.48
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants-5.212.89
Placebo/AAB-003Baseline (n=6,3,12,10,12,9)n=9 Participants81.116.25
Change at Week 52 (n=4,3,9,8,10,9)n=9 Participants-14.320.51

Behavior / neuropsychiatric

4 endpoints
Primary/protocol endpoint

Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 52

event count, event

Primary/registry result

Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgCompleted Suiciden=6 Participants0-
Suicide Attemptn=6 Participants0-
Imminent Suicidal Behaviorn=6 Participants0-
Suicidal Ideationn=6 Participants0-
Self-Injurious Behavior, No Suicidal Attemptn=6 Participants0-
AAB-003 1 mg/kgCompleted Suiciden=3 Participants0-
Suicide Attemptn=3 Participants0-
Imminent Suicidal Behaviorn=3 Participants0-
Suicidal Ideationn=3 Participants0-
Self-Injurious Behavior, No Suicidal Attemptn=3 Participants0-
AAB-003 2 mg/kgCompleted Suiciden=12 Participants0-
Suicide Attemptn=12 Participants0-
Imminent Suicidal Behaviorn=12 Participants0-
Suicidal Ideationn=12 Participants1-
Self-Injurious Behavior, No Suicidal Attemptn=12 Participants0-
AAB-003 4 mg/kgCompleted Suiciden=10 Participants0-
Suicide Attemptn=10 Participants0-
Imminent Suicidal Behaviorn=10 Participants0-
Suicidal Ideationn=10 Participants0-
Self-Injurious Behavior, No Suicidal Attemptn=10 Participants0-
AAB-003 8 mg/kgCompleted Suiciden=12 Participants0-
Suicide Attemptn=12 Participants0-
Imminent Suicidal Behaviorn=12 Participants0-
Suicidal Ideationn=12 Participants1-
Self-Injurious Behavior, No Suicidal Attemptn=12 Participants0-
Placebo/AAB-003Completed Suiciden=9 Participants0-
Suicide Attemptn=9 Participants0-
Imminent Suicidal Behaviorn=9 Participants0-
Suicidal Ideationn=9 Participants0-
Self-Injurious Behavior, No Suicidal Attemptn=9 Participants0-
Other/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52

Time frame:Baseline, Week 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52

Time frame:Baseline, Week 52

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,12,9)n=6 Participants11.27.65
Change at Week 52 (n=4,3,9,8,10,9)n=6 Participants-3.54.36
AAB-003 1 mg/kgBaseline (n=6,3,12,10,12,9)n=3 Participants12.013.45
Change at Week 52 (n=4,3,9,8,10,9)n=3 Participants5.71.15
AAB-003 2 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants7.16.99
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants5.18.39
AAB-003 4 mg/kgBaseline (n=6,3,12,10,12,9)n=10 Participants11.016.73
Change at Week 52 (n=4,3,9,8,10,9)n=10 Participants4.58.90
AAB-003 8 mg/kgBaseline (n=6,3,12,10,12,9)n=12 Participants9.610.24
Change at Week 52 (n=4,3,9,8,10,9)n=12 Participants0.112.54
Placebo/AAB-003Baseline (n=6,3,12,10,12,9)n=9 Participants3.93.92
Change at Week 52 (n=4,3,9,8,10,9)n=9 Participants13.923.00

Neuroimaging

2 endpoints
Primary/protocol endpoint

Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings

Time frame:Baseline up to Week 52

event count, event

Primary/registry result

Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgn=6 Participants1-
AAB-003 1 mg/kgn=3 Participants1-
AAB-003 2 mg/kgn=12 Participants0-
AAB-003 4 mg/kgn=10 Participants0-
AAB-003 8 mg/kgn=12 Participants0-
Placebo/AAB-003n=9 Participants1-

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to Week 52

event count, event

Primary/protocol endpoint

Number of Participants With Potentially Clinically Important Vital Sign Findings

Time frame:Baseline up to Week 52

change from baseline, event

Primary/protocol endpoint

Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings

Time frame:Baseline up to Week 52

event count, event

Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgNumber of Participants with AEsn=6 Participants5-
Number of Participants with SAEsn=6 Participants0-
AAB-003 1 mg/kgNumber of Participants with AEsn=3 Participants3-
Number of Participants with SAEsn=3 Participants1-
AAB-003 2 mg/kgNumber of Participants with AEsn=12 Participants9-
Number of Participants with SAEsn=12 Participants2-
AAB-003 4 mg/kgNumber of Participants with AEsn=10 Participants5-
Number of Participants with SAEsn=10 Participants3-
AAB-003 8 mg/kgNumber of Participants with AEsn=12 Participants10-
Number of Participants with SAEsn=12 Participants1-
Placebo/AAB-003Number of Participants with AEsn=9 Participants8-
Number of Participants with SAEsn=9 Participants1-
Primary/registry result

Number of Participants With Potentially Clinically Important Vital Sign Findings

Time frame:Baseline up to Week 52

change from baseline, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgSupine SBP <90 mm Hgn=6 Participants1-
Supine DBP <50 mm Hgn=6 Participants0-
Supine Pulse Rate <40 or >120 bpmn=6 Participants0-
Supine SBP >=30 mm Hg Increase from Baselinen=6 Participants3-
Supine DBP >=20 mm Hg Increase from Baselinen=6 Participants2-
Supine SBP >=30 mm Hg Decrease from Baselinen=6 Participants0-
Supine DBP >=20 mm Hg Decrease from Baselinen=6 Participants0-
AAB-003 1 mg/kgSupine SBP <90 mm Hgn=3 Participants0-
Supine DBP <50 mm Hgn=3 Participants0-
Supine Pulse Rate <40 or >120 bpmn=3 Participants0-
Supine SBP >=30 mm Hg Increase from Baselinen=3 Participants1-
Supine DBP >=20 mm Hg Increase from Baselinen=3 Participants1-
Supine SBP >=30 mm Hg Decrease from Baselinen=3 Participants1-
Supine DBP >=20 mm Hg Decrease from Baselinen=3 Participants1-
AAB-003 2 mg/kgSupine SBP <90 mm Hgn=12 Participants0-
Supine DBP <50 mm Hgn=12 Participants1-
Supine Pulse Rate <40 or >120 bpmn=12 Participants0-
Supine SBP >=30 mm Hg Increase from Baselinen=12 Participants1-
Supine DBP >=20 mm Hg Increase from Baselinen=12 Participants4-
Supine SBP >=30 mm Hg Decrease from Baselinen=12 Participants4-
Supine DBP >=20 mm Hg Decrease from Baselinen=12 Participants5-
AAB-003 4 mg/kgSupine SBP <90 mm Hgn=10 Participants0-
Supine DBP <50 mm Hgn=10 Participants3-
Supine Pulse Rate <40 or >120 bpmn=10 Participants0-
Supine SBP >=30 mm Hg Increase from Baselinen=10 Participants2-
Supine DBP >=20 mm Hg Increase from Baselinen=10 Participants5-
Supine SBP >=30 mm Hg Decrease from Baselinen=10 Participants1-
Supine DBP >=20 mm Hg Decrease from Baselinen=10 Participants3-
AAB-003 8 mg/kgSupine SBP <90 mm Hgn=12 Participants0-
Supine DBP <50 mm Hgn=12 Participants0-
Supine Pulse Rate <40 or >120 bpmn=12 Participants1-
Supine SBP >=30 mm Hg Increase from Baselinen=12 Participants4-
Supine DBP >=20 mm Hg Increase from Baselinen=12 Participants1-
Supine SBP >=30 mm Hg Decrease from Baselinen=12 Participants2-
Supine DBP >=20 mm Hg Decrease from Baselinen=12 Participants3-
Placebo/AAB-003Supine SBP <90 mm Hgn=9 Participants1-
Supine DBP <50 mm Hgn=9 Participants0-
Supine Pulse Rate <40 or >120 bpmn=9 Participants0-
Supine SBP >=30 mm Hg Increase from Baselinen=9 Participants1-
Supine DBP >=20 mm Hg Increase from Baselinen=9 Participants2-
Supine SBP >=30 mm Hg Decrease from Baselinen=9 Participants4-
Supine DBP >=20 mm Hg Decrease from Baselinen=9 Participants5-
Primary/registry result

Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgPR Interval >=300 msecn=6 Participants0-
QRS Complex >=200 msecn=6 Participants0-
QTcF Interval 450 to <480 msecn=6 Participants0-
QTcF Interval 480 to <500 msecn=6 Participants0-
QTcF Interval >=500 msecn=6 Participants0-
PR Interval >=25/50% Increase from Baselinen=6 Participants0-
QRS Complex >=25/50% Increase from Baselinen=6 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=6 Participants2-
QTcF Interval >=60 msec Change from Baselinen=6 Participants0-
AAB-003 1 mg/kgPR Interval >=300 msecn=3 Participants0-
QRS Complex >=200 msecn=3 Participants0-
QTcF Interval 450 to <480 msecn=3 Participants2-
QTcF Interval 480 to <500 msecn=3 Participants0-
QTcF Interval >=500 msecn=3 Participants0-
PR Interval >=25/50% Increase from Baselinen=3 Participants0-
QRS Complex >=25/50% Increase from Baselinen=3 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=3 Participants1-
QTcF Interval >=60 msec Change from Baselinen=3 Participants0-
AAB-003 2 mg/kgPR Interval >=300 msecn=12 Participants0-
QRS Complex >=200 msecn=12 Participants0-
QTcF Interval 450 to <480 msecn=12 Participants4-
QTcF Interval 480 to <500 msecn=12 Participants1-
QTcF Interval >=500 msecn=12 Participants1-
PR Interval >=25/50% Increase from Baselinen=12 Participants0-
QRS Complex >=25/50% Increase from Baselinen=12 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=12 Participants4-
QTcF Interval >=60 msec Change from Baselinen=12 Participants1-
AAB-003 4 mg/kgPR Interval >=300 msecn=10 Participants0-
QRS Complex >=200 msecn=10 Participants0-
QTcF Interval 450 to <480 msecn=10 Participants3-
QTcF Interval 480 to <500 msecn=10 Participants1-
QTcF Interval >=500 msecn=10 Participants0-
PR Interval >=25/50% Increase from Baselinen=10 Participants0-
QRS Complex >=25/50% Increase from Baselinen=10 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=10 Participants4-
QTcF Interval >=60 msec Change from Baselinen=10 Participants1-
AAB-003 8 mg/kgPR Interval >=300 msecn=12 Participants0-
QRS Complex >=200 msecn=12 Participants0-
QTcF Interval 450 to <480 msecn=12 Participants2-
QTcF Interval 480 to <500 msecn=12 Participants1-
QTcF Interval >=500 msecn=12 Participants0-
PR Interval >=25/50% Increase from Baselinen=12 Participants0-
QRS Complex >=25/50% Increase from Baselinen=12 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=12 Participants1-
QTcF Interval >=60 msec Change from Baselinen=12 Participants0-
Placebo/AAB-003PR Interval >=300 msecn=9 Participants0-
QRS Complex >=200 msecn=9 Participants0-
QTcF Interval 450 to <480 msecn=9 Participants2-
QTcF Interval 480 to <500 msecn=9 Participants0-
QTcF Interval >=500 msecn=9 Participants0-
PR Interval >=25/50% Increase from Baselinen=9 Participants0-
QRS Complex >=25/50% Increase from Baselinen=9 Participants0-
QTcF Interval >=30/<60 msec Change from Baselinen=9 Participants2-
QTcF Interval >=60 msec Change from Baselinen=9 Participants0-

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

Time frame:Baseline up to Week 52

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Abnormal Physical Examination Findings

Time frame:Baseline up to Week 52

event count, event

Primary/registry result/low confidence

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgn=6 Participants3-
AAB-003 1 mg/kgn=3 Participants2-
AAB-003 2 mg/kgn=12 Participants8-
AAB-003 4 mg/kgn=10 Participants7-
AAB-003 8 mg/kgn=12 Participants10-
Placebo/AAB-003n=9 Participants6-
Primary/registry result/low confidence

Number of Participants With Abnormal Physical Examination Findings

Time frame:Baseline up to Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgAbdomenn=6 Participants0-
Earsn=6 Participants0-
Extremitiesn=6 Participants0-
Eyesn=6 Participants1-
Generaln=6 Participants0-
Lymph Nodesn=6 Participants0-
Musculoskeletaln=6 Participants0-
Nosen=6 Participants1-
Skinn=6 Participants0-
Thyroidn=6 Participants0-
AAB-003 1 mg/kgAbdomenn=3 Participants0-
Earsn=3 Participants0-
Extremitiesn=3 Participants0-
Eyesn=3 Participants0-
Generaln=3 Participants0-
Lymph Nodesn=3 Participants1-
Musculoskeletaln=3 Participants1-
Nosen=3 Participants0-
Skinn=3 Participants0-
Thyroidn=3 Participants0-
AAB-003 2 mg/kgAbdomenn=12 Participants1-
Earsn=12 Participants0-
Extremitiesn=12 Participants0-
Eyesn=12 Participants0-
Generaln=12 Participants1-
Lymph Nodesn=12 Participants0-
Musculoskeletaln=12 Participants0-
Nosen=12 Participants0-
Skinn=12 Participants0-
Thyroidn=12 Participants0-
AAB-003 4 mg/kgAbdomenn=10 Participants0-
Earsn=10 Participants2-
Extremitiesn=10 Participants0-
Eyesn=10 Participants0-
Generaln=10 Participants0-
Lymph Nodesn=10 Participants0-
Musculoskeletaln=10 Participants0-
Nosen=10 Participants0-
Skinn=10 Participants2-
Thyroidn=10 Participants1-
AAB-003 8 mg/kgAbdomenn=12 Participants0-
Earsn=12 Participants1-
Extremitiesn=12 Participants0-
Eyesn=12 Participants0-
Generaln=12 Participants0-
Lymph Nodesn=12 Participants0-
Musculoskeletaln=12 Participants0-
Nosen=12 Participants0-
Skinn=12 Participants0-
Thyroidn=12 Participants0-
Placebo/AAB-003Abdomenn=9 Participants0-
Earsn=9 Participants0-
Extremitiesn=9 Participants1-
Eyesn=9 Participants0-
Generaln=9 Participants0-
Lymph Nodesn=9 Participants0-
Musculoskeletaln=9 Participants1-
Nosen=9 Participants0-
Skinn=9 Participants1-
Thyroidn=9 Participants0-
Other/protocol endpoint/low confidence

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer

Time frame:Baseline, Week 52

event count, event

Other_pre_specified/registry result/low confidence

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer

Time frame:Baseline, Week 52

event count, event

Posted result

GroupValue (number), participantsReported bounds
AAB-003 0.5 mg/kgBaseline (n=6,3,12,10,8)n=6 Participants0-
Week 52 (n=4,3,9,8,10,8)n=6 Participants0-
AAB-003 1 mg/kgBaseline (n=6,3,12,10,8)n=3 Participants0-
Week 52 (n=4,3,9,8,10,8)n=3 Participants0-
AAB-003 2 mg/kgBaseline (n=6,3,12,10,8)n=12 Participants0-
Week 52 (n=4,3,9,8,10,8)n=12 Participants0-
AAB-003 4 mg/kgBaseline (n=6,3,12,10,8)n=10 Participants0-
Week 52 (n=4,3,9,8,10,8)n=10 Participants0-
AAB-003 8 mg/kgBaseline (n=6,3,12,10,8)n=12 Participants0-
Week 52 (n=4,3,9,8,10,8)n=12 Participants0-
Placebo/AAB-003Baseline (n=6,3,12,10,8)n=9 Participants0-
Week 52 (n=4,3,9,8,10,8)n=9 Participants0-

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

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.