Status:
COMPLETED
Dapagliflozin In Alzheimer's Disease
Lead Sponsor:
Jeff Burns, MD
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
PHASE2
Brief 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) ...
Detailed Description
This is a double-blind, randomized, placebo-controlled, parallel group, 12-week study performed at a single site (University of Kansas Alzheimer's Disease Center) to investigate the effect of dapaglif...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures.
- Have a diagnosis of probable AD per McKhann et al. criteria
- Have a body mass index (BMI) ≥23
- Age 50-85
- Have a Mini Mental Status Exam (MMSE) score of 15-26 (inclusive) at screening visit
- Have a reliable and competent study partner who is willing to accompany the participant to all study visits, monitor compliance of study medication administration, and observe/report any changes in the participant's health throughout the study duration
- Are on stable doses of concurrent medications for at least 4 weeks prior to the screening visit
- Speaks English as his/her primary language.
- Females of child-bearing potential (i.e., pre-menopausal) must have a negative urine pregnancy test at the screening visit and must agree to use of contraception throughout the trial and for 30 days after the last dose of study medication. The approved methods of contraception are abstinence, the consistent use of an approved oral contraceptive (birth control pill or "the pill"), an intrauterine device (IUD), hormonal implants, contraceptive injection, double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam).
Exclusion
- Received an investigational product in another clinical study during the last 4 weeks prior to screening
- Diagnosis of Type 1 diabetes
- Diagnosis of Type 2 diabetes treated with insulin, sulfonylureas, glucagon like peptide1 receptor agonists (GLP-1), thiazolidinedione (TZD) or SGLT2 inhibitors (metformin monotherapy is allowed).
- Estimated Glomerular Filtration Rate (eGFR; MDRD) \<45 mL/min at screening or unstable renal disease.
- Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia.
- Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN. Total bilirubin \>2.0 mg/dL (34.2 μmol/L)
- Intolerance or allergy to dapaglifozin or any other SGLT2 inhibitor or any other substance in the tablets.
- Dementia due to causes other than AD
- History of recurrent urinary tract infection
- Active mycotic genital infection
- History of bladder cancer
- History of diabetic ketoacidosis
- Potentially confounding, serious, or unstable medical conditions such as:
- cancer within the past 3 years (except basal cell, squamous cell, or localized prostate cancer)
- a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 3 months prior to screening visit)
- other conditions that pose a potential safety risk or confounding factor in the investigator's opinion
- Any abnormal physical examination assessment or vital sign assessment at the screening visit that is deemed to be clinically significant by the principal investigator.
- Any abnormal clinical laboratory test result at the screening visit that is deemed to be clinically significant by the principal investigator.
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03801642
Start Date
January 29 2019
End Date
July 7 2022
Last Update
June 13 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160