Dapagliflozin In Alzheimer's Disease

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Jeff Burns, MD
Study ID
NCT03801642
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg oral tablets taken once daily for 12 weeks
  • Placebo — OTHER
    Placebo tablet (matched in size and color to active tablet) taken once daily for 12 weeks

Study Details

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.

Key Dates

Start date
Jan 29, 2019
Status verified
May 2024
Primary completion
Jul 7, 2022
Completion
Jul 7, 2022

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    10 mg dapagliflozin oral tablet taken once daily for 12 weeks
  • Placebo Comparator: Matching placebo
    Placebo oral tablet taken once daily for 12 weeks

Primary Outcome Measure

Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-

Find similar trials in Kansas City, KS

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Kansas Medical Center· Kansas City, KS

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