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NCT03801642 · ClinicalTrials.gov registry record · Phase 1
Dapagliflozin In Alzheimer's Disease
A Phase 1 study, sponsored by Jeff Burns, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT03801642: Completed Phase 1 study, sponsored by Jeff Burns, MD.
NCT03801642 is a Phase 1 study that has completed, run by Jeff Burns, MD. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801642, a Phase 1 study, has completed, sponsored by Jeff Burns, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a pilot randomized controlled trial in individuals with probable Alzheimer's disease testing the effects of 10 mg dapagliflozin, taken daily for 12 weeks, on cerebral n-acetyl aspartate (NAA) levels using magnetic resonance spectroscopy (MRS). The investigators will also examine the safety and tolerability of dapagliflozin and explore the effects on systemic NAA levels in blood and urine, cerebral metabolism (fluorodeoxyglucose \[FDG\] PET), systemic metabolic biomarkers that indicate and quantify secondary metabolic effects, and cognitive performance.
Primary Outcome
Estimated mean change from baseline in the ratio of cerebral NAA/ cerebral Creatine as measured by MRI Spectroscopy.
Interventions
- OTHER Placebo
- DRUG Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 1 |
What the finished NCT03801642 record still lists
NCT03801642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03801642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801642 about?
NCT03801642 is a clinical study titled "Dapagliflozin In Alzheimer's Disease". This is a pilot randomized controlled trial in individuals with probable Alzheimer's disease testing the effects of 10 mg dapagliflozin, taken daily for 12 weeks, on cerebral n-acetyl aspartate (NAA) levels using magnetic resonance spectroscopy (MRS). The investigators will also examine the safety a...
What is the current status of trial NCT03801642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-01-29. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT03801642?
The interventions under investigation include: Placebo (OTHER), Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT03801642?
This trial is sponsored by Jeff Burns, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03801642's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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