Week of May 10 - May 17, 2009
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| The CONCERT trial will explore the effects of adding Dimebon to Aricept. These medications are thought to have different mechanisms of action. |
Pfizer and Medivation, Inc. 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 FDA-approved donepezil HCI tablets (known in the U.S. by the brand name Aricept), the leading Alzheimer's disease (AD) medication worldwide, in patients with mild-to-moderate AD.
Aricept is the most common medication offered for the treatment of Alzheimer's symptoms. Dimebon is one of the most promising new medications for the treatment of Alzheimer's and Huntington's. It is in the advanced stages of clinical trials
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.
Design of the CONCERT Study
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 United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. Patients must be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four 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-RELATED NEWS ON THIS SITE
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Dimebon is one of the more promising medications in clinical trials. It appears to inhibit dementias such as Alzheimer's disease and Huntington's disease. New data shows how it may work by relieving oxidative stress.
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Two research studies lead this week's news. Researchers in Southampton found an Alzheimer's vaccine removed plaques yet showed no benefits. On the flipside, the Alzheimer's Association's Dr. Gandy called a new Dimebon study, "A pretty exciting development."
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VIDEO + TRANSCRIPT
Dimebon is an experimental Alzheimer's drug. Dimebon trials are getting national attention due to a recent episode from the TV series, "Boston Legal." Here's more about the famous episode and a Dimebon trial in Rochester, NY.
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MORE INFORMATION:
About the Pfizer/Medivation Dimebon Collaboration
Medivation and Pfizer have a global collaboration to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. Under the terms of the agreement, the companies are working in partnership to bring Dimebon to market in the United States (U.S.). In addition, following FDA approval, Medivation will co-promote Dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside of the U.S.
SOURCES:
Pfizer, Inc.
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