Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants
with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants
will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice
daily, for 52 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then
every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in
enhancing cognition and slowing cognitive and functional decline will be evaluated.