Long-Term Safety of Simufilam for Alzheimer's Disease

Recruiting at 134 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cassava Sciences, Inc.

Disqualifiers: Neurologic condition, Psychiatric diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 52 weeks

1081 Participants Needed

Trial Summary

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.

Research Team

James Kupiec, MD

Principal Investigator

Cassava Sciences, Inc.

Eligibility Criteria

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

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

Availability of a study partner

My condition is still showing signs of Alzheimer's disease.

Exclusion Criteria

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

Residence in a skilled nursing facility requiring 24-hour care

I have a brain condition, not Alzheimer's, causing my memory problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline

Baseline assessments conducted using clinical and laboratory assessments from the Week 76 (REFOCUS-ALZ) or Week 52 (RETHINK-ALZ) End-of-Treatment visit

1 day

1 visit (in-person)

Treatment

Participants receive simufilam 100 mg oral tablet, twice daily, with safety assessments every 12 weeks

52 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Simufilam

Trial Overview The trial is testing the long-term safety and effects of a drug named Simufilam at a dose of 100 mg. It’s an open-label extension, meaning everyone knows they are receiving Simufilam and there’s no placebo group involved.

Participant Groups

Group I: Simufilam 100 mg Experimental Treatment 1 Intervention

simufilam 100 mg oral tablet, twice daily

Who Is Running the Clinical Trial?

Cassava Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

3,400+