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NCT05352763 · ClinicalTrials.gov registry record · Phase 2
Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease
A Phase 2 study, sponsored by Cassava Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT05352763: Clinical Trial Phase 2 study, sponsored by Cassava Sciences.
NCT05352763 is a Phase 2 study that was terminated before completion, run by Cassava Sciences. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05352763, a Phase 2 study, was terminated before completion, sponsored by Cassava Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study 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.
Primary Outcome
Number of Participants with Adverse Events
Interventions
- DRUG simufilam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 2 |
Why NCT05352763 stopped before completion
NCT05352763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which simufilam is the first listed.
NCT05352763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05352763 about?
NCT05352763 is a clinical study titled "Open-Label Extension of the PTI-125-04 Study in Mild-to-Moderate Alzheimer's Disease". 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 si...
What is the current status of trial NCT05352763?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2022-05-12. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT05352763?
The interventions under investigation include: simufilam (DRUG).
Who is sponsoring clinical trial NCT05352763?
This trial is sponsored by Cassava Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05352763's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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