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