Medivation’s Dimebon improves memory in Alzheimer’s disease patients

The data included results of an analysis of the 11 subdomains of the Alzheimer’s disease Assessment Scale-cognitive subscale (ADAS-cog), a standardized measure of cognition in patients with Alzheimer’s disease (AD) and one of two endpoints the FDA has used to approve all currently marketed drugs for mild-to-moderate AD.

Results showed that Dimebon-treated patients were significantly improved compared with placebo on nine 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). These clinical results were generated during a pivotal trial of Dimebon in patients with mild-to-moderate AD. Medivation is planning to initiate a second, confirmatory pivotal Phase III trial of Dimebon in mild-to-moderate AD in the second quarter of 2008 with the goal of completing the trial and applying for US and European marketing approval in 2010. The company is also evaluating Dimebon in an ongoing Phase II clinical trial in mild-to-moderate Huntington's disease.