CompletedPhase 3

Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.

Lead sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Asset

Bapineuzumab

Listed sites

186

Recruiting sites

Enrollment

1,121

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Cognitive and Functional

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 IDELN115727-302

NCT IDNCT00575055

Timeline

Milestones

Study start2007-12 (month precision)

Study first posted2007-12-17estimated

Primary completion2012-04actual (month precision)

Study completion2012-04actual (month precision)

Last update posted2013-11-25estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age88 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD

•Age from 50 to less than 89

•Mini-Mental Status Exam score of 16-26 inclusive

•Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD

•Stable doses of medications (cholinesterase inhibitors and memantine allowed)

•Caregiver able to attend all clinic visits with patient

Exclusion criteria

•Significant neurological disease other than AD

•Major psychiatric disorder

•Significant systemic illness

•History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years

•Smoking greater than 20 cigarettes per day

•Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications

•Prior treatment experimental immunotherapeutics or vaccines for AD

•Women of childbearing potential

•Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Endpoints (3)

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.

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Cognitive and Functional

Time frame:18 months

descriptive

Secondary/protocol endpoint/low confidence

Cognitive and Global

Time frame:18 months

descriptive

Secondary/protocol endpoint/low confidence

Imaging and biochemical biomarkers of disease status

Time frame:18 months

categorical status, descriptive

Publications (6)

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 tableno registry results posted yet

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.