Status:
TERMINATED
Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
Lead Sponsor:
Cassava Sciences, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 an...
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 stud...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05352763
Start Date
May 12 2022
End Date
December 31 2024
Last Update
August 15 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Cognitive Clinical Trials
Gilbert, Arizona, United States, 85296
2
Valley Research Center, Inc.
Imperial, California, United States, 92251
3
Brain Matters Research
Delray Beach, Florida, United States, 33445
4
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912