Simufilam for Alzheimer's Disease

(REFOCUS-ALZ Trial)

Recruiting at 26 trial locations

Overseen By Stephen Thein, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Cassava Sciences, Inc.

Must not be taking: Anti-amyloid antibodies

Disqualifiers: Neurologic condition, Psychiatric diagnosis, Alcohol use, others

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: 14

Duration: 76 weeks

1083 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called simufilam to see if it can help people with mild-to-moderate Alzheimer's disease by improving their brain function and slowing down the progression of their symptoms.

Research Team

Jim Kupiec, MD

Principal Investigator

Cassava Sciences

Eligibility Criteria

This trial is for people with mild-to-moderate Alzheimer's who've had consistent Alzheimer's medication doses for 3+ months and haven't smoked in 3+ years. Participants need a study partner to attend screenings.

Inclusion Criteria

Are you experiencing the initial signs of memory loss or Alzheimer's disease?

My Alzheimer's medication dose has been stable for over 3 months.

I quit smoking more than 3 years ago.

Exclusion Criteria

I have not smoked for at least 3 years.

My Alzheimer's medication dose has been the same for the last 12 weeks.

, and not meeting the study inclusion criteria, was found in 96 of the 377 (25%) individuals screened

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive simufilam or placebo twice daily for 76 weeks to evaluate safety and efficacy in enhancing cognition and slowing cognitive decline

76 weeks

Clinic visits every 12 weeks, with an additional visit at 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Placebo
• Simufilam

Trial Overview The trial tests the safety and effectiveness of Simufilam, at either 50 mg or 100 mg doses, compared to a placebo over a period of 76 weeks. The goal is to see if it improves cognition or slows decline in Alzheimer's patients.

Participant Groups

Group I: Simufilam 50 mg Experimental Treatment 1 Intervention

Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks

Group II: Simufilam 100 mg Experimental Treatment 1 Intervention

Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks

Group III: Placebo Placebo Group 1 Intervention

Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks

Who Is Running the Clinical Trial?

Cassava Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

3,400+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD