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NCT04994483 · ClinicalTrials.gov registry record · Phase 3
Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease
A Phase 3 study, sponsored by Cassava Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 804
- Enrollment target
NCT04994483 is a Phase 3 study that has completed, run by Cassava Sciences. The registered enrollment target is 804 participants.
The verdict
NCT04994483, a Phase 3 study, has completed, sponsored by Cassava Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 804 participants
- Enrollment target
Study Summary
A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 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 | 804 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2024-10-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04994483
The ClinicalTrials.gov registry entry for NCT04994483 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 804 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.
NCT04994483 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04994483 about?
NCT04994483 is a clinical study titled "Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease". A 52-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 52 weeks. Approximately 750 participants will be randomized (1:1) to receive either placebo or 100 mg tablets of simufilam, twice daily, for 52 weeks. Clini...
What is the current status of trial NCT04994483?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2021-11-03. Estimated completion is 2024-10-02.
What interventions are being tested in trial NCT04994483?
The interventions under investigation include: Placebo (DRUG), Simufilam (DRUG).
Who is sponsoring clinical trial NCT04994483?
This trial is sponsored by Cassava Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
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