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NCT05026177 · ClinicalTrials.gov registry record · Phase 3
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
A Phase 3 study, sponsored by Cassava Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,125
- Enrollment target
NCT05026177: Clinical Trial Phase 3 study, sponsored by Cassava Sciences.
NCT05026177 is a Phase 3 study that was terminated before completion, run by Cassava Sciences. The registered enrollment target is 1,125 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05026177, a Phase 3 study, was terminated before completion, sponsored by Cassava Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,125 participants
- Enrollment target
Study Summary
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated.
Primary Outcome
The change from baseline to Week 76 in the ADAS-Cog12, a psychometrician-administered battery comprised of several cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Scores range from 0 (best) to 80 (worst).
Interventions
- DRUG Placebo
- DRUG Simufilam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,125 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 3 |
Why NCT05026177 stopped before completion
NCT05026177 is an interventional study that assigns participants to a tested intervention. Its 1,125 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05026177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05026177 about?
NCT05026177 is a clinical study titled "Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease". A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, ...
What is the current status of trial NCT05026177?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,125 participants. The study started on 2021-11-18. Estimated completion is 2024-12-30.
What interventions are being tested in trial NCT05026177?
The interventions under investigation include: Placebo (DRUG), Simufilam (DRUG).
Who is sponsoring clinical trial NCT05026177?
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 NCT05026177's enrollment target sits among peer trials
1,125 248th of 2000 higher than 1,753 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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