1083 Participants Needed

Simufilam for Alzheimer's Disease

(REFOCUS-ALZ Trial)

Recruiting at 26 trial locations
AH
SD
CC
TO
IY
JD
Perminder J Bhatia profile photo
Stephen Thein, MD profile photo
Overseen ByStephen Thein, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 3
Sponsor: Cassava Sciences, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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

JK

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.
See 1 more

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
See 1 more

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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Simufilam 50 mgExperimental Treatment1 Intervention
Simufilam 50 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Group II: Simufilam 100 mgExperimental Treatment1 Intervention
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 76 weeks
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 76 weeks

Find a Clinic Near You

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

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