The leading Alzheimer's disease medications

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Pfizer (NYSE: PFE) and Medivation, Inc. (Nasdaq: MDVN) announced the initiation of a 12-month, Phase 3 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 leading Alzheimer's disease (AD) medication worldwide, in patients with mild-to-moderate AD.

The CONCERT study is part of a broad, Phase 3 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 3 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 AD and builds on results of the first pivotal trial of Dimebon in AD.

"Due to the complexity of Alzheimer's disease, the condition often requires combination treatment to help relieve symptoms and slow disease progression," said Bengt Winblad, professor of geriatrics, Karolinska Institute. "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."

Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer's disease (AD) and in clinical development for Huntington's disease (HD). In preclinical models of AD and HD explored thus far, 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. The Dimebon mechanism is thought to be distinct from currently available AD medications. ... http://www.medicalnewstoday.com

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