Current Updates on Phase 3 Clinical Program
Background - Our Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer's disease dementia. The goal is to evaluate overall risk/benefit for simufilam 100 mg twice-daily versus placebo in a large population of people with Alzheimer's disease over 12 and 18 months.
The target study population is people with mild-to-moderate Alzheimer's (MMSE score of 16-27) who are biomarker-positive for Alzheimer's disease pathology, and who meet other inclusion/exclusion eligibility criteria of the study protocols.