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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: Completed Phase 3 study, sponsored by Cassava Sciences.
NCT04994483 is a Phase 3 study that has completed, run by Cassava Sciences. The registered enrollment target is 804 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change from baseline to Week 52 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 | 804 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2024-10-02 |
| Phase | Phase 3 |
What the finished NCT04994483 record still lists
NCT04994483 is an interventional study that assigns participants to a tested intervention. The registered 804 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04994483 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04994483's enrollment target sits among peer trials
804 412th of 2000 higher than 1,588 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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