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Research
Introduction
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ADRC Research
Autopsy Program
Healthy Volunteering
Investigator Requests
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A Phase III, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of Bapineuzumab (AAB-001) in Subjects with Alzheimer's Disease
| Study Director |
Adam Boxer, MD, PhD |
| Sponsor |
Elan Pharmaceuticals, Inc. |
| Recruiting? |
Yes |
| Official Study Title |
A Phase III, 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 (ApoE4) Carriers and Non-Carriers |
| Conditions Studied |
Mild-moderate Alzheimer's disease |
| Intervention |
Bapineuzumab, a monoclonal antibody administered via intravenous infusion that is designed to help remove amyloid protein (the presumed cause of Alzheimer's disease) from the brain. |
| Purpose |
To determine safety and efficacy of multiple doses of bapineuzumab in ApoE4 carriers and non-carriers. You will be enrolled into one of two studies depending on whether or not you have the ApoE4 allele. |
| Eligibility |
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| Inclusion Criteria |
Subjects must be between 50 and 89 years old, meet criteria for Alzheimer's disease, and have a study partner who sees them at least 5 times a week be able to accompany them to all study visits. Subjects may take Aricept, Exelon, Razadyne and/or Namenda but must be on stable doses of these medications for 4 months. Subjects must be willing and able to have brain MRIs through the course of the study. Subjects must also have an MMSE score between 16 and 26, inclusive, at time of screening. |
| Exclusion Criteria |
History of stroke or seizures, history of substance abuse or heart attack within the last 2 years or most types of cancer within the last 5 years. Current treatment with anticoagulant (blood thinners) medication, anti-seizure medication, or narcotic medications. Pacemakers, shrapnel, or other metal implants in body also exclude subjects from participating. |
| What is Involved? |
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| Testing |
Neurological and physical examinations, MRIs, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, vital signs, genetic testing. |
| Frequency of Visits |
15 visits over 20 months. (~1 visit every 6-7 weeks) |
| Contact Information |
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| Coordinator |
Jessica Hall |
| Phone |
(415) 476-0700 |
| Materials Needed prior to Evaluation |
Diagnosis of probable Alzheimer's disease |
| Costs |
None. Parking will be validated for Milberry Parking Garage for all study visits, and subjects will be reimbursed $40 per visit for meal and travel expenses. |
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