Medivation's Dimebon(TM) Significantly Improved Thinking and Memory in Alzheimer's Disease Patients Ove... (with AD and one of two endpoints the U.S...)

Medivation's Dimebon(TM) Significantly Improved Thinking and Memory in Alzheimer's Disease Patients Over One Year

Date:4/17/2008

with AD and one of two endpoints the U.S. Food and Drug Administration (FDA) has used to approve all currently marketed drugs for mild-to-moderate AD. In the study, ADAS-cog was assessed at the beginning of the study and at weeks 12, 26, 39 and 52.

Results showed that Dimebon-treated patients were significantly improved compared with placebo on 9 of the 11 ADAS-cog subdomains after one year of treatment. Benefits were observed in memory (word recall, p=0.04; word recognition, p=0.03; remembering instructions, p=0.10); orientation (p= 0.01); constructional praxis (the ability to copy simple drawings or patterns, p=0.005) and ideational praxis (the ability to perform a familiar but complex sequence of actions, p=0.006); and language (following commands, p<0.0001; naming objects, p<0.0001; word finding, p=0.005; comprehension, p=0.15; overall language, p=0.0002).

"We have recently presented a number of different findings from our first pivotal trial of Dimebon at scientific conferences, demonstrating that this investigational drug has a beneficial impact on the key aspects of Alzheimer's disease -- from behavioral symptoms to thinking and memory problems to impairments in daily function," said Lynn Seely, M.D., chief medical officer of Medivation. "Medivation is committed to rapidly developing Dimebon as a treatment for mild-to-moderate Alzheimer's disease to make it available to the millions of people who suffer from this increasingly prevalent disease, for which new treatment options are desperately needed."

Dimebon Showed Statistically Significant Benefit Versus Placebo on All Key Efficacy Endpoints

Medivation previously announced efficacy and safety results from the pivotal, 12-month, double-blind, placebo-controlled trial of Dimebon in 183 patients with mild-to-moderate AD. Dimebon improved the clinical course of Alzheimer's disease patients by causing statistically significant improvements over placebo in each of the five primary aspe
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