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NCT04388254 · ClinicalTrials.gov registry record · Phase 2
Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients
A Phase 2 study, sponsored by Cassava Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
NCT04388254: Completed Phase 2 study, sponsored by Cassava Sciences.
NCT04388254 is a Phase 2 study that has completed, run by Cassava Sciences. The registered enrollment target is 220 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04388254, a Phase 2 study, has completed, sponsored by Cassava Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
Study Summary
A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for participants of the previous simufilam studies as wells as additional new mild-to-moderate Alzheimer's disease subjects for a total of 200 participants. All participants will receive simufilam 100 mg tablets twice daily for one year, followed by a 6-month randomized, double-blind period where subjects will either continue on active treatment or be switched to placebo. The study concludes with an additional 6-month open-label treatment period. Clinic visits are every month or month and a half in the first year, and every 3 months in the second year with an additional visit at Month 13. Cognition and neuropsychiatric symptoms are evaluated.
Primary Outcome
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11-item: Change from baseline in cognition over the course of 24 months Possible range in score: 0-70; Subscales are summed; Higher values represent a more cognitively impaired participant Decrease in mean value represents improvement in cognition from one timepoint to the next.
Interventions
- DRUG Placebo
- DRUG Simufilam 100 mg oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-03-24 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 2 |
What the finished NCT04388254 record still lists
NCT04388254 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04388254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04388254 about?
NCT04388254 is a clinical study titled "Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients". A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for participants of the previous simufilam studies as wells as additional new mild-to-moderate Alzheimer's disease subjects for a total of 200 participants. All participants will receive simufilam 100 mg tablets twice dai...
What is the current status of trial NCT04388254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2020-03-24. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT04388254?
The interventions under investigation include: Placebo (DRUG), Simufilam 100 mg oral tablet (DRUG).
Who is sponsoring clinical trial NCT04388254?
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 NCT04388254's enrollment target sits among peer trials
220 275th of 2000 higher than 1,718 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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