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A Phase 3 Study Evaluating Dimebon in Alzheimer's Patients on Donepezil

Status:	Active and Recruiting
Eligible Population(s):	Alzheimer's Disease
GCO Number:	09-0279 IRB approved through 03/23/2010
Principal Investigator:	Hillel Grossman, MD
Study Coordinator:	Andrew Vigario

Mount Sinai researchers will be participating in a phase 3 study being conducted nationwide to evaluate how well and how safe a study medication, Dimebon, is in combination with donepezil (Aricept®) in patients diagnosed with mild-to-moderate Alzheimer’s disease (AD). This research study will work to evaluate whether Dimebon may improve both the function and outgrowth of brain cells, which is often compromised in a number of neurodegenerative diseases such as AD. Further, the study will evaluate whether Dimebon could provide improvements in cognition and activities of daily living when given in combination with donepezil.

Study participants will receive active study drug or placebo (inactive pill) for 12 months for the duration of the study, while continuing to take the prescribed donepezil. All participants will be carefully monitored at the research clinic throughout the study, and will be compensated for transportation to and from the clinic.

Participants are eligible to participate if they meet the following criteria:

• are 50 years of age or older and have mild-to-moderate AD
• have a Mini-Mental State Examination (MMSE) score of 12-24, inclusive
• have a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan consistent with a diagnosis of probable AD within 12 months prior
• have been taking donepezil for at least six months, with stable dosing at 10mg/day for at least the last four months
• have a caregiver who is able to attend all study visits.