Over 800 patients with mild Alzheimer's disease enrolled in the study will take 800 mg twice daily of either Flurizan or placebo and attend periodic physician visits for analysis of their performance on memory, cognition and behavioral tests.
The two primary clinical endpoints of the trial are the change in cognitive decline and function, as measured by the Alzheimer's disease Assessment Scale – cognitive subscale and changes in activities of daily living, as measured by the Alzheimer's disease Cooperative Study – Activities of Daily Living inventory. A secondary endpoint of the trial is the change in overall function, measured by the Clinical Dementia Rating – sum of boxes test.
Myriad has already conducted a double-blinded, placebo-controlled phase II trial of Flurizan for 12 months duration in 207 patients with mild to moderate Alzheimer's disease with patients in the UK and Canada.