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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cassava Sciences, Inc.

Criteria

• Subjects must have completed the PTI-125-04 study.