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| Sponsored by: |
Elan Pharmaceuticals |
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00574132 |
Purpose
This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada 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.
| Condition | Intervention | Phase |
|
Alzheimer's Disease |
Drug: Bapineuzumab Drug: Placebo Control |
Phase III |
| Genetics Home Reference related topics: | Alzheimer disease |
| MedlinePlus related topics: | Alzheimer's Disease |
| ChemIDplus related topics: | Bapineuzumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | 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. |
| Estimated Enrollment: | 1250 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Active Comparator | Drug: Bapineuzumab |
| B: Active Comparator | Drug: Bapineuzumab |
| C: Active Comparator | Drug: Bapineuzumab |
| D: Placebo Comparator | Drug: Placebo Control |
Eligibility
| Ages Eligible for Study: | 50 Years to 88 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Study Coordinator | 1-866-446-5463 |
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Show 158 Study Locations |
| Elan Pharmaceuticals |
More Information
| Responsible Party: | Elan Pharmaceuticals ( Michael Grundman ) |
| Study ID Numbers: | ELN115727-301 |
| First Received: | December 10, 2007 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00574132 |
| Health Authority: | United States: Food and Drug Administration |
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