Simufilam for Alzheimer's Disease

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cassava Sciences, Inc.

Disqualifiers: Non-completion of PTI-125-04

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

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

Compensation: Varies

Number of Visits: 12

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves patients with mild-to-moderate Alzheimer's disease taking simufilam regularly. It aims to see if the medication is safe and effective over time. Simufilam works by targeting proteins in the brain that are associated with Alzheimer's.

Eligibility Criteria

This clinical trial is open to individuals with mild-to-moderate Alzheimer's Disease who have completed the PTI-125-04 study. It's designed to assess long-term treatment effects and safety over a period of 96 weeks.

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive simufilam 100 mg b.i.d. for long-term treatment and safety evaluation

96 weeks

Clinic visits every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• simufilam

Trial Overview The trial is testing simufilam, given at a dose of 100 mg twice daily (b.i.d.). The focus is on understanding its safety and effectiveness when used over an extended time in those previously involved in the initial Phase 2 study.

Participant Groups

Group I: Simufilam 100 mg Experimental Treatment 1 Intervention

simufilam 100 mg oral tablets, b.i.d.

Who Is Running the Clinical Trial?

Cassava Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

3,400+