Medivation announced that patient enrollment was completed for its Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) evaluating the potential efficacy of Dimebon when added to ongoing treatment with donepezil. The international, randomized, double-blind, placebo-controlled 12-month trial (CONCERT) enrolled 1,003 patients with mild-to-moderate AD at approximately 100 sites around the world. Patients on a stable dose of donepezil were randomized to one of three treatment groups: Dimebon 20mg three times per day, Dimebon 5mg three times per day or placebo. Patients were required to be on treatment with donepezil for at least 6 months and at a stable dose of 10mg daily for at least 4 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.
Dimebon is an investigational oral antihistamine being co-developed by Medivation and Pfizer as a potential treatment for Alzheimer’s disease and Huntington disease. Latrepirdine is the proposed generic (nonproprietary) name for Dimebon.