More than 120 sites across the US have been enlisted and most are now screening and enrolling patients into the study. Myriad anticipates completing enrollment for the 12-month study during the first half of 2006 with results of the phase III trial to be reported in the third calendar quarter of 2007.
Myriad used the results of its phase II trial of Flurizan, which were presented at the Alzheimer’s Association International Conference on Prevention of Dementia in June, to fine tune its phase III trial.
The phase II study indicated that patients with mild Alzheimer’s disease treated with 800mg Flurizan twice daily, experienced the greatest benefit, with a 34% slowing in the rate of cognitive decline. This finding also guided Myriad to size the study to show statistical significance given a 30% improvement versus placebo with 90% confidence.
“We believe that the phase III trial of Flurizan in Alzheimer’s disease is well-powered to convincingly demonstrate the impressive therapeutic effect that was seen in mild Alzheimer’s disease in the phase II trial,” said Dr Adrian Hobden, president of Myriad Pharmaceuticals. “By concentrating on the mild population, using the higher 800mg dose, and maintaining consistency among most of the other study variables, we believe we have paved the way for a successful trial.”