Simufilam for Alzheimer's Disease
(RETHINK-ALZ Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications, but any Alzheimer's medications must be stable for at least 12 weeks, and other chronic medications must be stable for at least 4 weeks before joining the study.
How is the drug Simufilam different from other Alzheimer's treatments?
What is the purpose of this trial?
This trial tests simufilam, a pill taken twice daily, on people with mild-to-moderate Alzheimer's disease. The goal is to see if it can improve memory and slow down the worsening of symptoms by helping the brain work better and reducing harmful swelling. The study will last for about a year and involve periodic check-ups to monitor safety and effectiveness.
Research Team
James Kupiec, MD
Principal Investigator
Cassava Sciences
Eligibility Criteria
This trial is for adults with mild-to-moderate Alzheimer's Disease who have been stable on current AD medications for at least 12 weeks, have a certain range of cognitive function scores, and haven't smoked in 3+ years. They need a study partner and can't join if they've had recent seizures or strokes, uncontrolled diabetes or hypertension, severe psychiatric conditions, specific BMI limits, or are taking certain other AD drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive simufilam or placebo twice daily for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Simufilam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cassava Sciences, Inc.
Lead Sponsor
Premier Research Group plc
Industry Sponsor
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