Medivation Completes Enrollment In Phase 3 'CONCERT' Trial Of Dimebon Added To Donepezil In Patients With Alzheimer's Disease
SAN FRANCISCO, Dec. 7, 2010 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that patient enrollment was completed on November 30, 2010 in the CONCERT study, a 12-month, Phase 3 clinical trial in patients with mild-to-moderate Alzheimer's disease (AD) evaluating the potential efficacy of dimebon (latrepirdine*) when added to ongoing treatment with donepezil. Medivation is conducting this study under its collaboration agreement with Pfizer Inc.
"Completing patient enrollment in CONCERT is an important step forward for our dimebon development program in Alzheimer's disease," said Lynn Seely, M.D., chief medical officer of Medivation. "Now that enrollment is complete, we expect to report top-line results from the CONCERT trial in the first half of 2012. We have previously received feedback from the FDA confirming that we can use our Phase 3 CONCERT trial to complete our registration package for mild-to-moderate Alzheimer's disease, provided that the results are robustly positive."
The international, randomized, double-blind, placebo-controlled Phase 3 CONCERT trial enrolled 1,003 patients with mild-to-moderate AD at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo. Patients were required to be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in the study. 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.
About DimebonDimebon (latrepirdine*) is an investigational oral medication being tested as a potential treatment for Alzheimer's disease and Huntington disease. In addition to the CONCERT trial, dimebon is also being tested in the HORIZON trial, a six-month Phase 3 study evaluating dimebon in patients with Huntington disease. Medivation expects to report top-line results from the HORIZON trial in the first half of 2011. For further information on dimebon clinical trials, please visit www.dimebontrials.com or www.clinicaltrials.gov. About Alzheimer's Disease Alzheimer's disease is a progressive degenerative brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as delusions, hallucinations, anxiety and agitation.
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