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NCT04669028 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of NE3107 in Probable Alzheimer's Disease
A Phase 3 study, sponsored by BioVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
NCT04669028 is a Phase 3 study that has completed, run by BioVie. The registered enrollment target is 439 participants.
The verdict
NCT04669028, a Phase 3 study, has completed, sponsored by BioVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
Study Summary
U.S. multicenter, parallel group study designed to evaluate the safety and efficacy of oral 20 mg twice daily (BID) NE3107 vs placebo in 400 adult subjects with mild to moderate probable AD. Dual co-primary endpoints (Clinical Dementia Rating Scale Sum of Boxes, CDR-SB and ADAS-Cog12) will be evaluated as the change from Baseline to Week 30. Secondary endpoints include measures of cognition, neuropsychological deficits, functional performance, and glycemic control. A subset of patients may volunteer for exploratory magnetic resonance imaging (volumetric changes) and positron emission tomography (cortical glucose metabolic rate) scans at baseline and week 30.
Interventions
- DRUG Placebo
- DRUG NE3107
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2023-10-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04669028
The ClinicalTrials.gov registry entry for NCT04669028 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 439 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioVie, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04669028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04669028 about?
NCT04669028 is a clinical study titled "A Phase 3 Study of NE3107 in Probable Alzheimer's Disease". U.S. multicenter, parallel group study designed to evaluate the safety and efficacy of oral 20 mg twice daily (BID) NE3107 vs placebo in 400 adult subjects with mild to moderate probable AD. Dual co-primary endpoints (Clinical Dementia Rating Scale Sum of Boxes, CDR-SB and ADAS-Cog12) will be evalua...
What is the current status of trial NCT04669028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2021-08-05. Estimated completion is 2023-10-25.
What interventions are being tested in trial NCT04669028?
The interventions under investigation include: Placebo (DRUG), NE3107 (DRUG).
Who is sponsoring clinical trial NCT04669028?
This trial is sponsored by BioVie, which has 6 total clinical trials registered on ClinicalTrials.gov.
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