Phase 3 study of Dimebon and donepezil combination therapy for Alzheimer’s disease

Pfizer and Medivation, Inc announced the initiation of a 12-month, Phase 3 trial of the investigational drug Dimebon in combination with donepezil HCl for the treatment of mild-to-moderate Alzheimer’s disease (AD).  The study, known as CONCERT, is a randomized, double-blind, placebo-controlled study enrolling approximately 1,050 patients at about 100 sites internationally. Patients on a stable dose of donepezil will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) – a measure of self-care and daily function.

In preclinical models of AD and Huntington’s disease (HD), Dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction.

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