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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 is a Phase 3 study that was terminated before completion, run by Cassava Sciences. The registered enrollment target is 1,125 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05026177
The ClinicalTrials.gov registry entry for NCT05026177 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cassava Sciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05026177 reports 0 study locations.
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.
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