Medivation was saying this morning that new data will be presented at the American Academy of Neurology Annual Meeting next week. Maybe, but I can't find any new data in this abstract. Can you?
>>[S51.003] Dimebon Improves Cognition, Function, and Behavior in Patients with Mild- Moderate Alzheimers Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Study
Rachelle Doody, Houston, TX, Svetlana Gavrilova, Moscow, Russian Federation, Mary Sano, Bronx, NY, Ronald Thomas, La Jolla, CA, Paul Aisen, Washington, DC, Lynn Seely, David Hung, San Francisco, CA
OBJECTIVE: To assess the efficacy and safety of Dimebon in the treatment of mild to moderate AD. BACKGROUND: Dimebon is a novel small molecule which inhibits neuronal death, possibly through modulation of mitochondrial-mediated apoptosis, and improves cognition in models of AD. DESIGN/METHODS: 183 Russian patients with mild to moderate AD (MMSE 10-24 inclusive) were randomized to Dimebon, 20 mg orally three times daily, or placebo for 6 months. Patients were evaluated with the ADAS-cog (primary outcome, change in ADAS-cog score at week 26), CIBIC-plus, MMSE, NPI, and ADL at baseline, week 12 and week 26. Concomitant treatment with other AD medications was not allowed. RESULTS: Mean baseline MMSE was 18.5 (SD 3.4). 84% of patients completed the trial (Dimebon 87.6%; placebo 81.9%). Intention-to-treat (LOCF) analyses are reported. Dimebon treatment resulted in statistically-significant improvements in ADAS-cog, CIBIC-plus, MMSE, NPI, and ADL change scores relative to placebo. Mean drug-placebo differences were: ADAS-cog (4.0, p < 0.0001); CIBIC-plus (0.6 units, p<0.0001); MMSE (2.2, p< 0.0001); NPI (3.6, p= 0.006), and ADL (3.4, p= 0.0016). Treatment with Dimebon also resulted in significant improvements in all 5 endpoints compared to mean baseline scores. In an analysis by severity, both patients with mild AD (MMSE>18) and moderate AD (MMSE 18) demonstrated improvement, with moderate patients experiencing greater improvement than mild patients. The most common adverse event in Dimebon-treated patients was dry mouth (13.5%). Fewer Dimebon-treated patients experienced serious adverse events than placebo patients (2.2% vs. 7.4%). Gastrointestinal side effects occurred in <3% of patients. CONCLUSIONS/RELEVANCE: After 6 months Dimebon-treated patients were significantly improved compared to placebo patients on all five efficacy endpoints, and were also improved compared to baseline on all five endpoints. Dimebon is a novel, well-tolerated drug that improved cognition, function, and behavior in patients with mild-moderate AD. Supported by: Medivation, Inc.<<
Is the ITT analysis a better or worse way of analyzing he data for this indication?
TIA &Cheers, Tuck |
