← Trials/Trial dossier/NCT00112073

CompletedPhase 2

AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

Lead sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Asset

Bapineuzumab

Listed sites

Recruiting sites

Enrollment

234

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Safety assessments

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 IDAAB-001-201

NCT IDNCT00112073

Timeline

Milestones

Study start2005-04 (month precision)

Study first posted2005-05-30estimated

Primary completion2008-11actual (month precision)

Study completion2008-12actual (month precision)

Last update posted2012-03-14estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD

•Age from 50 to 85 years

•Rosen Modified Hachinski Ischemic score less than or equal to 4

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

•Fluency in English

•Stable doses of medications

Exclusion criteria

•Significant neurological disease other than AD

•Major psychiatric disorder

•Significant systemic illness

•History of stroke or seizure

•Weight greater than 120 kg (264 lbs.)

•History of autoimmune disease

•Smoking more than 20 cigarettes per day

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

•Prior treatment with experimental immunotherapeutics or vaccines for AD

•Presence of pacemakers 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.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

safety assessments

Time frame:18 months

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

blood levels of administered study drug

Time frame:18 months

descriptive

Secondary/protocol endpoint/low confidence

cognitive and functional assessments

Time frame:18 months

descriptive

Publications (2)

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.