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UnknownPhase 2

Safety Study of Passive Immunization for 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

Asset

Bapineuzumab

Listed sites

2

Recruiting sites

-

Enrollment

-

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

NCT IDNCT00174525
Org study IDPRI#585

Timeline

Milestones

Study start2005-04 (month precision)
Study first posted2005-09-15estimated
Study completion2008-04 (month precision)
Last update posted2012-05-09estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll

Inclusion criteria

•Diagnosis of probable AD
•Age from 50 to 85 years, inclusive
•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 120kg (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)
2
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety assessments

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Blood levels of administered study drug

descriptive

Secondary/protocol endpoint/low confidence

Cognitive and functional assessments

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.