Pfizer and Medivation to initiates Phase III trial for Alzheimer’s disease

Pfizer and Medivation, a biopharmaceutical company reported the initiation of 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, for patients with mild-to-moderate Alzheimer’s disease.

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 6-month Connection study, which is designed to evaluate the safety and efficacy of Dimebon monotherapy in patients with mild-to-moderate Alzheimer’s disease and builds on results of the first pivotal trial of Dimebon in Alzheimer’s disease.

Dimebon is an investigational compound currently in Phase III development for the treatment of Alzheimer’s disease and in clinical development for Huntington’s disease.

Bengt Winblad, professor of geriatrics, Karolinska Institute, said: “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 Alzheimer’s disease.”