Neurochem completes Ph III Alzhemed trial

Canadian drugmaker Neurochem has completed a Phase III clinical trial of Alzhemed (tramiprosate), its treatment for Alzheimer's disease. The 18-month North American study involved 1,052 patients, at 67 clinical sites across the USA and Canada. According to the firm, 791 were exposed to study medication for 18 months and completed their last visit, as per protocol, except for two patients whose last study visits are anticipated this week. The firm says it is on schedule to release the top-line results of the clinical trial in the spring of this year.

The primary objective of the multicenter, randomized, double-blind, placebo-controlled, three-armed, parallel-designed study is to investigate the safety, efficacy and disease-modifying potential of Alzhemed for the treatment of mild-to-moderate AD patients. Efficacy endpoints include the evaluation of cognitive abilities and a global measure of performance, utilizing the Alzheimer's Disease Assessment Scale-cognitive subscale and Clinical Dementia Rating-Sum of the Boxes scores, respectively. An open-label Phase III extension study was initiated in May 2006 and approximately 90% of the patients who completed the North American Phase III clinical trial have opted to continue receiving Alzhemed.