Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
Reason given: Sponsor Decision
Key facts
- Where
- Austin, Columbus, Delray Beach, Fort Myers, Gilbert, Imperial, Palmetto Bay, Papillion, and Toms River, United StatesSee the 9 sites
- Phase
- Phase 2
Where in United States
- Senior Adults Specialty ResearchAustin, United StatesNo longer taking part
- The Ohio State UniversityColumbus, United StatesNo longer taking part
- Brain Matters ResearchDelray Beach, United StatesNo longer taking part
- Neuropsychiatric Research Center of Southwest FloridaFort Myers, United StatesNo longer taking part
- Cognitive Clinical TrialsGilbert, United StatesNo longer taking part
- Valley Research Center, Inc.Imperial, United StatesNo longer taking part
- IMIC ResearchPalmetto Bay, United StatesNo longer taking part
- Cognitive Clinical TrialsPapillion, United StatesNo longer taking part
- Advanced Memory Research Institute of NJToms River, United StatesNo longer taking part
Trial details
- Who runs it
- Cassava Sciences, Inc.
- Trial code
- NCT05352763
- Record updated
- 15 August 2025
- Original description
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.Read full original descriptionShow less
An Open-Label Extension of the PTI-125-04 Study Evaluating the Safety and Long-Term Treatment of Simufilam in Mild-to-Moderate Alzheimer's Disease Patients
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.
Must have completed the PTI-125-04 study or Week 96 in the PTI-125-09 study; Male subjects must be willing to continue use of contraception during the study. With female partners of childbearing potential, male subjects, regardless of their fertility status, must agree to either remain abstinent or use condoms in combination with one additional highly effective method of contraception (e.g., oral or implanted contraceptives, or intrauterine devices) or an effective method of contraception (e.g., diaphragms with spermicide or cervical sponges) during the study and for 14 days after study drug dosing has been completed.