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A Phase III, Multi-Center, 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
We are seeking patients with mild to moderate Alzheimer's disease to evaluate the tolerability, safety and effectiveness of a new investigational drug that may be a possible treatment for Alzheimer's disease. Bapinuzemab is an investional drug not currently-approved by the US Food and Drug Administration (FDA).
Subjects will be randomly-assigned (i.e., by chance, like the flip of a coin) to receive drug or placebo (contains no active medication). This drug is given intravenously (i.e., through a vein). Study participants must be able to have an MRI. Study participants will be reimbursed for parking. All information is kept completely confidential.
1. Age of equal or greater than fifty years.
2. Diagnosis of mild to moderate Alzheimer's disease.
3. Have been on stable doses of FDA-approved treatments such as Aricept, Razadyne, Exelon and/or Namenda (Memantine) for at least four months.
4. A study partner or caregiver who is willing to come to fifteen clinic visits over the course of one-and-a-half years.
1. Significant neurological disease other than Alzheimer's disease.
2. Clinically-significant and/or un-controlled medical condition.
3. Use of an investigational drug within ninety days prior to the screening visit or during the entire study.
Martha Vander Vliet, RN
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