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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: Completed Phase 3 study, sponsored by BioVie.
NCT04669028 is a Phase 3 study that has completed, run by BioVie. The registered enrollment target is 439 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
test of 6 cognitive or functional domains, including memory, orientation, judgment, community affairs, home hobbies, and personal care are scored by certified raters after interviewing both participants and their informants. Higher score is indicative of more severe disease. The minimum score is 0 and the maximum score is 18. The CDR-SB is a co-primary outcome with ADAS-Cog12
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 |
What the finished NCT04669028 record still lists
NCT04669028 is an interventional study that assigns participants to a tested intervention. The registered 439 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04669028 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04669028's enrollment target sits among peer trials
439 872nd of 2000 higher than 1,127 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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