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Dapagliflozin In Alzheimer's Disease

NCT03801642 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-06-13

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Dapagliflozin

10 mg oral tablets taken once daily for 12 weeks

OTHER

Placebo

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

Sponsors & Collaborators

  • Jeff Burns, MD

    lead OTHER

Principal Investigators

  • Jeffrey Burns, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2022-07-07
Completion
2022-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03801642 on ClinicalTrials.gov