Sunday, March 11, 2007

Clinical Trial of Dimebon
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Dimebon is a weak inhibitor of cholinesterases, and has selectivity for butyryl cholinesterase over acetylcholinesterase, which may be of some concern for GI side effects.
The first clinical trial of Dimebon (by Medivation, conducted in Russia) demonstrated efficacy in five independent measures of cognitive improvement. The study randomized 183 patients to two groups: Dimebon, 20 mg. orally tid or placebo. Patients had mild to moderate Alzheimer disease (MMSE 10-24) and were not taking other medications to treat AD. Compared with patients receiving placebo, patients treated with Dimebon demonstrated highly statistically significant improvement on the study's primary efficacy endpoint, the ADAS-cog; 4.0 point improvement in the mean change from baseline to week 26 as compared to placebo; and on the key secondary efficacy endpoint, the Clinical Interview-Based Impression of Change, as well as statistically significant improvements on all three of the other secondary efficacy endpoints: the Activities of Daily Living, the Neuropsychiatric Inventory, and the Mini-Mental State Examination. 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. By contrast, placebo-treated patients deteriorated from baseline on all five endpoints (Medivation disclosure).
In a recent 6-month trial (in Russia, concluded in July 2006) Dimebon was well-tolerated. There were fewer serious adverse events in the Dimebon-treated patients than in the placebo-treated patients. The most common adverse event was dry mouth. All other gastrointestinal side effects were uncommon, occurring in less than 3 percent of patients (Medivation disclosure). Toxicological studies performed in the former Soviet Union in rats, guinea pigs, or dogs showed that administration of Dimebon at doses up to 100 times therapeutic dose did not produce physiological or pathological changes in major organs, including embryogenesis in rats.

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