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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 is a Phase 2 study that has completed, run by Cassava Sciences. The registered enrollment target is 220 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04388254
The ClinicalTrials.gov registry entry for NCT04388254 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 220 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.
NCT04388254 reports 0 study locations.
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.
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