Tramiprosate Falls Short in Phase III Alzheimer's Trial : Unusually large placebo effect could be a recurring problem in studies that allow concomitant medications.

The data may, however, be used to modify the primary analysis plan for the ongoing European phase III trial, which includes 966 patients in 10 countries. Recruitment for that trial is complete, but significant changes are possible, including changes to the study cohort, duration of treatment, and the statistical analysis, Dr. Garceau said. A company-appointed special advisory board will review the North American trial data, suggest any changes to the European trial, and ultimately recommend to Neurochem the fate of tramiprosate.

Despite the failure, 'it remains too early to heavily discount the amyloid hypothesis.' DR. CASELLI