Open-label Extension for Phase 3 Clinical Trials of Simufilam

• Status: Enrolling by invitation
• Trial end date: 2026-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cassava Sciences, Inc.

Criteria

Inclusion Criterion:

• Completed RETHINK-ALZ (PTI-125-07) or REFOCUS-ALZ (PTI-125-06).

• Clinical presentation continues to be consistent with Alzheimer's disease.

• Availability of a study partner.

Exclusion Criteria:

• Residence in a skilled nursing facility requiring 24-hour care.

• Evidence of a neurologic condition other than AD that significantly contributes to the subject's dementia.

• Current clinically significant psychiatric diagnosis other than AD.

• Unstable, clinically significant medical condition other than AD.

• Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study.