Study:
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 Non- Carriers.
Rationale:
n/a
Purpose:
This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple
dose study in male and female patients ages 50 to less than 89 years with mild to moderate
AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North
America will be involved. Patients will be randomized to receive either bapineuzumab or
placebo. Each patient`s participation will last approximately 1.5 years.
Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid
peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Alzheimer`s Disease |
Drug: Bapineuzumab
Drug: Placebo Control |
Phase 3 |
Verified by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
July, 2012
Sponsored by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov identifier: NCT00574132
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United States
n/a