First Alzheimer’s TrialDimebon's first Alzheimer's trial was a randomized, double-blind, placebo-controlled study of 183 patients with mild-to-moderate Alzheimer's disease performed in Russia. In this study, patients treated with dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function – after both six months and a full year of treatment. Dimebon was well tolerated in this trial. Results of the study were published in the July 19, 2008 issue of The Lancet. Click here for press release and click here for publication. CONNECTION TrialCONNECTION was a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate Alzheimer's disease in the U.S., Western Europe, Chile and Russia. Data from this trial have been reported and showed that dimebon did not meet any of its co-primary or secondary efficacy endpoints, but that it was well tolerated. The study endpoints in this trial were the same as those used in the first Alzheimer’s disease trial in Russia. Click here for press release. Phase 3 Safety StudyDimebon was evaluated in a multi-center, placebo-controlled Phase 3 safety and tolerability study involving 742 patients with mild-to-moderate Alzheimer's disease in the U.S. and Canada. In this study, dimebon was well tolerated when given alone or in combination with a variety of other Alzheimer’s disease medicines, including cholinesterase inhibitors, memantine, or both. Click here for press release. Clinical Trial StatusWe are currently enrolling patients with Alzheimer’s disease in a Phase 3 dimebon clinical trial known as CONCERT. The CONCERT study is a 12-month, randomized, double-blind, placebo-controlled trial in patients with mild-to-moderate Alzheimer’s disease who are already being treated with donepezil, the leading Alzheimer’s disease medication worldwide. |
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