drugset / Trial / NCT05352763
Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-05-12
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Outcome
Outcome not reported
Stopped (Business): “Sponsor Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simufilam | Small molecule | 100 mg | Oral |