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Medivation's Dimebon Maintains Statistically Significant Benefit on,All Five Efficacy Endpoints in Alzheimer's Disease Trial After One,Year of Therapy

e ADAS-cog difference reached statistical significance (observed case analysis; p=0.006). Dimebon's benefit over placebo on the other two endpoints (the MMSE and the NPI) at six months was maintained at one year.

Jeffrey Cummings, MD, the Augustus Rose Professor of Neurology at the University of California, Los Angeles, and Director of the UCLA Alzheimer's Disease Center stated: "I consider these efficacy data to be noteworthy because they show an overall treatment benefit that is consistent, robust and larger at twelve months than at six. To my knowledge, this is the first randomized, double-blind, placebo-controlled study in which statistically significant benefit was achieved on endpoints measuring each of the four most clinically relevant aspects of mild-to-moderate Alzheimer's disease after a full year of therapy. Given these data and the fact that Dimebon was well tolerated in this study, I consider Dimebon one of the most promising Alzheimer's disease compounds in development."

"The natural history of untreated Alzheimer's disease includes decline in thinking abilities, social behavior and function," observed Rachelle Doody, MD, PhD, the Effie Marie Cain Chair in Alzheimer's Disease Research at the Alzheimer's Disease and Memory Disorders Center, in Houston, and principal investigator of this study. "By contrast, after a full year of therapy Dimebon-treated patients did not decline in any of these areas. These data demonstrate that, as a group, Dimebon-treated patients stabilized for a full year, whereas placebo-treated patients declined at the expected rate."

Dimebon-treated patients experienced significantly fewer serious adverse events than placebo-treated patients (3.4 percent vs. 11.7 percent, respectively; p=0.03) and dropped out of the study at a rate (31.5 percent) consistent with the dropout rate in the placebo group (37.2 percent). The most frequently reported adverse events associated with treatment were dry mouth (18.0 percent
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