Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 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
- NCT05026177
- Run by
- Cassava Sciences, Inc.
- People needed
- 1125
- Starts
- 2021-11-18
- Expected to finish
- 2024-12-30
- Last updated by the study team
- 2025-09-22
Who can join
Age: 50 and older, up to 87. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Neuroscience Research, LLC — Phoenix, Arizona, United States
- Clinical Endpoints — Scottsdale, Arizona, United States
- Banner Sun Health Research Institute — Sun City, Arizona, United States
- Banner Alzheimer's Institute - Tucson — Tucson, Arizona, United States
- North County Neurology Associates — Carlsbad, California, United States
- Neuro-Pain Medical Center — Fresno, California, United States
- Neurology Center of North Orange County — Fullerton, California, United States
- Healthy Brain Clinic — Long Beach, California, United States
- California Research Insitute — Los Angeles, California, United States
- Shankle Clinic and Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- Pacific Research Network, LLC — San Diego, California, United States
- Nuvance Health Medical Practice CT, Inc. - Associated Neurologists, PC — Danbury, Connecticut, United States
- Ki Health Partners, LLC — Stamford, Connecticut, United States
- JEM Research Institute — Atlantis, Florida, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
- Clinical Research of Brandon, LLC — Brandon, Florida, United States
- Quantum Laboratories — Deerfield Beach, Florida, United States
- Brain Matters Research Inc — Delray Beach, Florida, United States
- Indago Research and Health Center, Inc. — Hialeah, Florida, United States
- Alphab Global Research — Jupiter, Florida, United States
- K2 Medical Research — Maitland, Florida, United States
- Mind Institute at Miami Jewish Health — Miami, Florida, United States
- Brainstorm Research — Miami, Florida, United States
- Health Synergy Clinical Research — Okeechobee, Florida, United States
- Banner Alzheimer's Institute — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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