US drugmaker Myriad Genetics has completed enrollment of patients in a global Phase III clinical trial of Flurizan (tarenflurbil) in Alzheimer's disease. The ActEarliAD study is a multinational, randomized, double-blind, placebo-controlled evaluation of Flurizan in over 800 patients with mild AD, who will be followed for 18 months.
According to Myriad, patients in the study will take 800mg twice daily of 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 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. Additional exploratory outcome measures are designed to assess the psychological, physical and financial impact of this disease on caregivers and medical resources. Myriad noted that the trial is designed to meet the requirements of the European Medicines Agency (EMEA) for marketing approval of Flurizan in Europe.
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