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| Descriptive Information Fields | |||||
| Brief Title † | Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease | ||||
| 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 Carriers. | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment | ||||
| Primary Outcome Measure † | Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ] | ||||
| Condition † | Alzheimer's Disease | ||||
| Intervention † | Drug: Bapineuzumab Drug: Placebo Control |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 800 | ||||
| Start Date † | December 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 88 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00575055 | ||||
| Organization ID | ELN115727-302 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Elan Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † | |||||
| Information Provided By | Elan Pharmaceuticals | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | December 10, 2007 | ||||
| Last Updated Date | August 19, 2008 | ||||