Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
Completed · Phase 3 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.
Key facts
- Study ID
- NCT04994483
- Run by
- Cassava Sciences, Inc.
- People needed
- 804
- Starts
- 2021-11-03
- Expected to finish
- 2024-10-02
- Last updated by the study team
- 2025-05-25
Who can join
Age: 50 and older, up to 87. Sex: any. Healthy volunteers: not accepted.
Where it is running
- CCT Research - Gilbert Neurology Partners — Gilbert, Arizona, United States
- Xenoscience, Inc. — Phoenix, Arizona, United States
- Advanced Research Center, Inc — Anaheim, California, United States
- Axiom Research, LLC — Colton, California, United States
- ATP Clinical Research, Inc. — Costa Mesa, California, United States
- Sun Valley Research Center, Inc. — Imperial, California, United States
- Senior Clinical Trials — Laguna Hills, California, United States
- Artemis Institute for Clinical Research — Riverside, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- Mountain Neurological Research Center — Basalt, Colorado, United States
- Colorado Neurological Research Center, PC — Denver, Colorado, United States
- CT Clinical Research — Cromwell, Connecticut, United States
- Topaz Clinical Research — Apopka, Florida, United States
- Neurology Offices of South Florida — Boca Raton, Florida, United States
- Boynton Beach Medical Research Institute (GMI) — Boynton Beach, Florida, United States
- K2 Medical Research - Clermont — Clermont, Florida, United States
- Arrow Clinical Trials — Daytona Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
- Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
- Galiz Research — Hialeah, Florida, United States
- Infinity Clinical Research - Sunrise — Hollywood, Florida, United States
- CNS Healthcare - Jacksonville — Jacksonville, Florida, United States
- Charter Research — Lady Lake, Florida, United States
- Segal Trials - West Broward Outpatient Site — Lauderhill, Florida, United States
- MDFirst Research — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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