Medivation And Pfizer Axe their new Alzheimer's drug Dimebon

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Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials
Article Date: 17 Jan 2012 - 12:00 PST

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Pfizer Inc. and Medivation, Inc. announced results from their 'CONCERT' trial today. CONCERT is a Phase 3 trial that evaluated dimebon (latrepirdine), which is used to treat patients with mild-to-moderate Alzheimer's disease. Dimebon is added to ongoing treatment with donepezil HCL tablets.

Although the drug was well tolerate by patients, unfortunately Dimebon did not appear to achieve the required results for either of the two tests assigned to the trial : the Alzheimer's Disease Assessment Scale, a cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer's Disease Cooperative Study, Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

David Hung, M.D., president and CEO of Medivation said :

"We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers ... I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial."

Medivation and Pfizer have said they will now discontinue development of dimebon, and the companies also announced that they will cease their collaboration to co-develop and market dimebon.

Steven J. Romano, M.D., senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. said :

"We recognize Alzheimer's is a very complex disease ... Despite this disappointing result, Pfizer remains committed to advancing the science of Alzheimer's disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients."

The Phase 3 CONCERT trial was a 12-month global randomized, double-blind, placebo-controlled trial that enrolled 1,003 patients with Alzheimer's disease. Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.

It's a blow not only to sufferers of the disease, but also to general public global health, with Alzheimer's predicted to affect one in 85 people by 2050. It's a frustrating disease for sufferers and their close friends and family, as brain function is reduced and memory loss, difficulty thinking, disorientation and forgetfulness start to take over the person's mind. Although there have been some promising developments, and the CONCERT trial initially appeared hopeful, scientists are still struggling to understand exactly how and why the disease progresses.

Written by Rupert Shepherd
Copyright: Medical News Today
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