Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants
with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants
will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg
tablets of simufilam, twice daily, for 76 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.