Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
- Registration Number
- NCT05352763
- Lead Sponsor
- Cassava Sciences, Inc.
- Brief Summary
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.
- Detailed Description
This is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the Phase 2 study, PTI-125-04. All subjects will provide consent to enroll into this study. Simufilam will be administered as coated oral tablets. The last study visit, Month 24, from the PTI-125-04 study will be used for the Study Day 1 visit assessments in this extension study. Clinic visits will occur every 12 weeks ±10 days. A complete physical examination will be performed at Study Day 1, Week 48 and Week 96. Subjects will return to the clinic every 12 weeks for safety assessments of vital signs, AE monitoring, C-SSRS, and drug dispensation and accountability. Blood draws for clinical laboratory testing, urine collection for urinalysis, and ECGs will be performed at Study Day 1 and Weeks 24, 48, 72, and 96. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale (C-SSRS).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Simufilam 100 mg simufilam simufilam 100 mg oral tablets, b.i.d.
- Primary Outcome Measures
Name Time Method Adverse Event Monitoring Baseline to 96 Weeks Adverse Event Monitoring
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Cognitive Clinical Trials
🇺🇸Papillion, Nebraska, United States
Advanced Memory Research Institute of NJ
🇺🇸Toms River, New Jersey, United States
IMIC Research
🇺🇸Palmetto Bay, Florida, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
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
the Ohio State University
🇺🇸Columbus, Ohio, United States
Toronto Memory Program ULC
🇨🇦Toronto, Ontario, Canada