Simufilam for Alzheimer's Disease (RETHINK-ALZ Trial)
Recruiting in Palo Alto (17 mi)
+106 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Cassava Sciences, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
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
You have mild to moderate dementia, with a score between 0.5 and 2 on a global rating scale.
My condition is in the middle to late stages of Alzheimer's according to specific research criteria.
Evidence for AD pathophysiology, confirmed either prior to or during screening.
MMSE score ≥ 16 and ≤ 27 at screening.
My Alzheimer's medication dose has been the same for the last 12 weeks.
You cannot participate if you have previously been in a clinical trial for an experimental drug that targets Alzheimer's disease.
Participant Groups
The study tests the safety and effectiveness of Simufilam (100 mg) compared to a placebo over one year. Participants will take the drug twice daily and attend clinic visits every few months to assess changes in cognition and ability to perform daily activities.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Simufilam 100 mgExperimental Treatment1 Intervention
Simufilam 100 mg, supplied by Cassava as coated tablets, and taken b.i.d. for 52 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo, supplied by Cassava as coated tablets, and taken twice daily (b.i.d.) for 52 weeks
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Renstar Medical ResearchOcala, FL
Stedman Clinical TrialsTampa, FL
Boston Neuro Research CenterNorth Dartmouth, MA
Ascension Via Christi ResearchWichita, KS
More Trial Locations
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Who is running the clinical trial?
Cassava Sciences, Inc.Lead Sponsor
Premier Research Group plcIndustry Sponsor