Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease

Stopped early · Phase 2

Conditions studied: Alzheimer's Disease

In brief

This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, and C-SSRS.

Key facts

Study ID

NCT05352763

Run by

Cassava Sciences, Inc.

People needed

90

Starts

2022-05-12

Expected to finish

2024-12-31

Last updated by the study team

2025-08-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Cognitive Clinical Trials — Gilbert, Arizona, United States
• Valley Research Center, Inc. — Imperial, California, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• IMIC Research — Palmetto Bay, Florida, United States
• Cognitive Clinical Trials — Papillion, Nebraska, United States
• Advanced Memory Research Institute of NJ — Toms River, New Jersey, United States
• the Ohio State University — Columbus, Ohio, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic — Ottawa, Ontario, Canada
• Toronto Memory Program ULC — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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