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Home » MEDIVATION REPORTS POSITIVE RESULTS FROM ALZHEIMER'S TRIAL
MEDIVATION REPORTS POSITIVE RESULTS FROM ALZHEIMER'S TRIAL
September 22, 2006
Medivation announced that its proprietary drug Dimebon met all five efficacy endpoints in a six-month randomized, double-blinded, placebo-controlled Phase II clinical study of 183 patients with mild to moderate Alzheimer's disease conducted at 11 sites in Russia. Compared with patients receiving placebo, patients treated with Dimebon demonstrated highly statistically significant improvement on the study's primary efficacy endpoint, the Alzheimer's Disease Assessment Scale-cognition (ADAS-cog), with a 4.0-point improvement in the mean change from baseline to week 26 compared with placebo, and on the key secondary efficacy endpoint, the Clinical Global Impression of Change (CGIC), with a 0.6-point improvement in the mean change from baseline to week 26 as compared with placebo. Dimebon-treated patients also achieved statistically significant improvement compared with placebo patients on all three of the other secondary efficacy endpoints.
In addition to these improvements in comparison to placebo, Dimebon-treated patients also showed statistically significant improvement over baseline on all five efficacy endpoints used in this study. In contrast, placebo-treated patients deteriorated from baseline on all five endpoints.
Dimebon was well-tolerated in this study. There were fewer serious adverse events in Dimebon-treated patients than in placebo-treated patients. No gastrointestinal side effects occurred in more than 3 percent of the Dimebon-treated patients except for dry mouth, which occurred in 13.5 percent of the Dimebon-treated patients. A higher percentage of Dimebon-treated patients than placebo-treated patients completed the trial, for an overall trial completion rate of 84.7 percent.
KEYWORDS Drug Pipeline Alert
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