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

Study Status: 
Closed
Study Description: 

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.

 

ELIGIBILITY CRITERIA

 

Inclusion criteria:

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.

 

Exclusion criteria:

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.

Study Coordinator(s): 

Martha Vander Vliet, RN

Tel:  617-732-8085

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