Pfizer and Medivation, a biopharmaceutical company, have initiated a 12-month, Phase III clinical trial of the investigational drug Dimebon. The study, known as Concert, is designed to evaluate the safety and efficacy of Dimebon when added to ongoing treatment with donepezil HCI tablets, the Alzheimer’s disease medication worldwide, in patients with mild-to-moderate AD.
The Concert study is part of a broad, Phase III clinical development program for Dimebon. The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated.
Concert is designed to complement previous and ongoing studies by further evaluating the efficacy of Dimebon. The Phase III program also includes the confirmatory six-month Connection study, which is designed to evaluate the safety and efficacy of Dimebon monotherapy in patients with mild-to-moderate Alzheimer’s disease (AD) and builds on results of the first pivotal trial of Dimebon in AD.
The international, randomized, double-blind, placebo-controlled study will enroll approximately 1,050 patients with mild-to-moderate AD at approximately 100 sites in the US, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil will be randomized to one of three treatment groups: Dimebon 20mg three times per day, Dimebon 5mg three times per day or placebo. Patients must be on treatment with donepezil for at least six months and at a stable dose of 10mg daily for at least four months prior to enrollment in the study.
The primary endpoints are the Alzheimer’s disease assessment scale – cognitive subscale and the Alzheimer’s disease cooperative study – activities of daily living – a measure of self-care and daily function.
Dimebon is an investigational compound currently in Phase III development for the treatment of AD and in clinical development for Huntington’s disease.
Bengt Winblad, professor of geriatrics at Karolinska Institute, said: Due to the complexity of Alzheimer’s disease, the condition often requires combination treatment to help relieve symptoms and slow disease progression. The Concert trial will explore the potential additive effects of Dimebon to ongoing donepezil therapy, two drugs thought to have different mechanisms of action. We believe this trial may serve to demonstrate the potential of Dimebon in AD.