Phenserine Did Not Achieve Significant Efficacy in Alzheimer's Disease Trial

The top-line outcome of Axonyx's first Phase III clinical trial with Phenserine, in development for mild-to-moderate Alzheimer's disease (AD), showed that although there were encouraging trends with both Phenserine 10 mg and 15 mg twice daily, overall these did not result in a statistically significant improvement over placebo for the protocol's primary endpoints following 26 weeks of treatment.

While Phenserine-treated patients performed better in the ADAS-cog and CIBIC assessments, the study's primary endpoints at almost all time points, the outcome was potentially confounded by a better than expected ADAS-cog response in the placebo-treated patients.

A preliminary review of the adverse events has revealed no safety or tolerability concerns associated with Phenserine treatment. Axonyx is continuing to further analyze the data and will use this valuable information to optimize the trial designs in the currently planned program. The Phase III trial recruited 384 mild-to-moderate Alzheimer's patients from 16 clinical sites in Spain, UK, Croatia and Austria.

Patients, after being diagnosed as having probable AD, were randomized to receive placebo, Phenserine 10 mg twice daily or 15 mg twice daily for a period of six months. Throughout the treatment period patients were regularly assessed using standard cognition and memory assessments.