TerminatedPhase 2Results posted

Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥9

Primary endpoint

•Clinically Significant Magnetic Resonance Imaging (MRI) 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 ID3133L1-2204

Secondary IDB2521009Alias Study Number

NCT IDNCT00916617

Timeline

Milestones

Study start2009-06 (month precision)

Study first posted2009-06-09estimated

Primary completion2012-09actual (month precision)

Study completion2012-09actual (month precision)

Last update posted2017-06-01actual

Results first posted2017-06-01actual

Assets

Drug assets

Bapineuzumab

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 disease

•Completed preceding double-blind study (3133L1-2203 US)

•MMSE score > 9

Exclusion criteria

•Significant brain MRI abnormalities

•Clinically important psychiatric symptoms

•History of stroke

Endpoints (4)

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

Neuroimaging

Safety / tolerability / PK

Neuroimaging

2 endpoints

Primary/protocol endpoint

Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings

Time frame:Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

event count, event

Primary/registry result

Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings

Time frame:Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Bapineuzumab (5 mg + 5 mg)Week 13n=23 Participants	0	-
Week 26n=23 Participants	1	-
Week 39n=23 Participants	0	-
Week 52n=23 Participants	0	-
Week 65n=23 Participants	0	-
Week 78n=23 Participants	0	-
Week 91n=23 Participants	0	-
Week 104n=23 Participants	0	-
Week 117n=23 Participants	0	-
Week 130n=23 Participants	0	-
Week 143n=23 Participants	0	-
Week 156n=23 Participants	0	-
Any visitn=23 Participants	1	-
Bapineuzumab (10 mg + 10 mg)Week 13n=21 Participants	2	-
Week 26n=21 Participants	0	-
Week 39n=21 Participants	0	-
Week 52n=21 Participants	0	-
Week 65n=21 Participants	0	-
Week 78n=21 Participants	1	-
Week 91n=21 Participants	0	-
Week 104n=21 Participants	0	-
Week 117n=21 Participants	0	-
Week 130n=21 Participants	0	-
Week 143n=21 Participants	0	-
Week 156n=21 Participants	0	-
Any visitn=21 Participants	3	-
Placebo + Bapineuzumab 5mgWeek 13n=10 Participants	1	-
Week 26n=10 Participants	1	-
Week 39n=10 Participants	0	-
Week 52n=10 Participants	0	-
Week 65n=10 Participants	0	-
Week 78n=10 Participants	0	-
Week 91n=10 Participants	0	-
Week 104n=10 Participants	0	-
Week 117n=10 Participants	0	-
Week 130n=10 Participants	0	-
Week 143n=10 Participants	0	-
Week 156n=10 Participants	0	-
Any visitn=10 Participants	1	-
Placebo + Bapineuzumab 10 mgWeek 13n=7 Participants	0	-
Week 26n=7 Participants	0	-
Week 39n=7 Participants	0	-
Week 52n=7 Participants	0	-
Week 65n=7 Participants	0	-
Week 78n=7 Participants	0	-
Week 91n=7 Participants	0	-
Week 104n=7 Participants	0	-
Week 117n=7 Participants	0	-
Week 130n=7 Participants	0	-
Week 143n=7 Participants	0	-
Week 156n=7 Participants	0	-
Any visitn=7 Participants	0	-

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination

Time frame:36 months

time to event, event

Secondary/registry result

Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination

Time frame:36 months

time to event, event

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.