27 April 2009

Phase 3 trial of dimebon added to donepezil (Aricept)

Pfizer and Medivation initiate phase 3 trial of dimebon added to donepezil in patients with Alzheimer's disease
Medivation: 15 April 2009
Pfizer and Medivation 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. …. > full press release

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