Long-Term Safety of Simufilam for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
James Kupiec, MD
Principal Investigator
Cassava Sciences, Inc.
Are You a Good Fit for This Trial?
This trial is for people who have Alzheimer's Disease and were part of earlier Phase 3 trials called RETHINK-ALZ or REFOCUS-ALZ. Participants need a study partner and must still show symptoms consistent with Alzheimer's. Those in full-time nursing care, with other significant neurological conditions, unstable medical issues, or serious psychiatric diagnoses besides Alzheimer's cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments conducted using clinical and laboratory assessments from the Week 76 (REFOCUS-ALZ) or Week 52 (RETHINK-ALZ) End-of-Treatment visit
Treatment
Participants receive simufilam 100 mg oral tablet, twice daily, with safety assessments every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Simufilam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cassava Sciences, Inc.
Lead Sponsor