April 15, 2009
Phase 3 study of Dimebon and donepezil combination therapy for Alzheimer's diseasePfizer 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.
For more information call (877) 888-6386 or visit www.concertstudy.com.