The Phase III clinical trial for the treatment of Alzheimer's
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Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) has issued an update on the progress made since announcing in April 2007 that adjustments would be required to arrive at a reliable statistical model for the North American Phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD). Neurochem has been advised by its external team of statisticians that they have made progress adjusting the statistical model, reaching an acceptable level of validity for the disease modification endpoint, as measured by magnetic resonance imaging (MRI). However, further work is required to reach a reliable model particularly for the co-primary clinical efficacy endpoint composed of ADAS-cog(1) and CDR-SB(2). Therefore, the Company expects the results to be available later in 2007.
The North American study was a multicenter, randomized, double-blind, placebo-controlled, three-armed and parallel-designed, 18-month Phase III clinical trial. The study included 1,052 patients with mild-to-moderate AD recruited across 67 sites in Canada and the United States randomized to receive either placebo or one of two doses (100mg or 150mg twice daily) of tramiprosate (ALZHEMED(TM)). All patients were required to be treated with conventional symptomatic AD therapies during the clinical trial and were required to be on a stable dose of such therapies for at least four months prior to the initial screening visit of the trial. At study entry, patients in this trial had been administered standard therapies for an average of approximately 20 months.

All patients who completed the clinical trial were eligible to receive tramiprosate (ALZHEMED(TM)) in an open-label extension study initiated in May 2006. Approximately 90% of the patients who completed the Phase III double-blind study for tramiprosate (ALZHEMED(TM)) elected to enroll in the ongoing extension study and receive 150mg twice daily of tramiprosate (ALZHEMED(TM)).

Neurochem is also currently conducting a European Phase III clinical trial for tramiprosate (ALZHEMED(TM)) for the treatment of AD. The European study is of a similar design to the North American double-blind trial and over 950 mild-to-moderate AD patients are already enrolled at about 70 clinical centers across 10 European countries. To date, the European Data Safety Monitoring Board has met three times and recommended on each occasion that the study should continue as planned. The Company expects to continue patient enrolment and is presently considering modifications that would need to be made to the design of the European trial to take best advantage of the experience gained from the North American Phase III clinical trial.