AXONYX ANNOUNCES RESULTS OF ALZHEIMER'S DISEASE TRIALS
Axonyx has announced the results of its two curtailed Phase III clinical trials with Phenserine, in development for mild-to-moderate Alzheimer's disease (AD). Results following 12 weeks of treatment, as measured by the Alzheimer's Disease Assessment Scale, cognitive subscale and Clinical Interview Based Impression of Change with caregiver input, did not demonstrate a statistically significant benefit of Phenserine treatment over placebo.
Patient recruitment for these studies had previously been halted and the planned 26-week treatment period shortened based on previously released results of a 375-patient trial which had showed no statistically significant differences between Phenserine and placebo. There were no safety or tolerability concerns associated with Phenserine treatment.
The combined trials recruited 255 mild-to-moderate probable AD patients from 72 clinical sites in 10 countries. Throughout the 12-week treatment period patients were regularly assessed using standard cognition and memory assessments. Neither of the two Phenserine doses used showed a significant benefit as compared to placebo treatment.