CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03801642
NCT03801642Phase 2Completed
CompareCT.gov

Randomized Controlled Pilot Trial Of Dapagliflozin In Alzheimer's Disease

Jeff Burns, MD·interventional·Posted Jan 11, 2019·Updated Jun 13, 2024

In Brief

A Phase 2 clinical trial evaluating Dapagliflozin and Placebo for Alzheimer Disease. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 11, 2019
Enrollment StartJan 29, 2019
Primary CompletionJul 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.5 years ago

Interventions

Dapagliflozindrug

10 mg oral tablets taken once daily for 12 weeks

Placeboother

Placebo tablet (matched in size and color to active tablet) taken once daily for 12 weeks