TerminatedPhase 3

A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

Lead sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Asset

Bapineuzumab

Listed sites

191

Recruiting sites

Enrollment

896

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Clinically important changes in safety assessment results

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 IDELN115727-351

NCT IDNCT00937352

Timeline

Milestones

Study start2009-07 (month precision)

Study first posted2009-07-13estimated

Primary completion2012-09actual (month precision)

Study completion2012-09actual (month precision)

Last update posted2013-12-20estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD

•Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)

•Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71

•Caregiver able to attend all clinic visits with patient

Exclusion criteria

•Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study

•Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment

•Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Endpoints (2)

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

Other (unclassified)

Neuroimaging

1 endpoint

Primary/protocol endpoint

Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.

Time frame:Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.

Time frame:The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first

descriptive

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.