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www.fdanews.com/articles/69855-axonyx-releases-further-results-of-phenserine-trial-in-alzheimer-s-disease

Axonyx Releases Further Results of Phenserine Trial in Alzheimer's Disease

March 15, 2005

Axonyx has reported additional detailed information from its first Phase III clinical trial with Phenserine, in development for mild-to-moderate Alzheimer's disease (AD).

Although Phenserine demonstrated trends toward efficacy in the primary efficacy variables, no statistically significant differences between the efficacy of the active and placebo groups were observed in areas of cognition, global function, behavior and activities of daily living.

The Phase III trial involved 375 patients from 11 different clinical sites in Austria, Croatia, Spain and the UK. After being diagnosed with probable AD, patients were randomized to receive placebo, Phenserine 10 mg twice daily or 15 mg twice daily, for a period of six months. The primary efficacy parameters were the Alzheimer's Disease Assessment Scale, cognitive subscale and the Clinical Interview Based Impression of Change with caregiver input. Additional study endpoints included the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale and the Neuropsychiatric Inventory.