Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
Status:
Enrolling by invitation
Trial end date:
2025-11-29
Target enrollment:
Participant gender:
Summary
This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate
Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will
evaluate safety and long-term treatment. Subjects will be followed on ADAS-Cog11 and NPI
until 96 weeks. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital
signs, ECGs, GDS and C-SSRS.