Start: February 2019
End: July 2022
What Is This Study About?
This study will test the effects, safety, and tolerability of dapagliflozin, also known as Farxiga, in adults with mild to moderate Alzheimer's disease. Researchers are investigating whether this drug can slow Alzheimer's disease. In this 12-week study participants will be randomly assigned to take a tablet of either 10 mg of dapagliflozin or placebo once a day. Dapagliflozin is approved by the U.S. Food and Drug Administration to lower blood pressure in people with type 2 diabetes. Researchers will assess the effects of the drug on mitochondrial function (how a cell processes food into energy) which may play a role in processes related to Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Diagnosis of probable Alzheimer's disease
- Body mass index of 23 or higher
- Mini-Mental Status Examination score of 15 to 26
- 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
- On stable doses of concurrent medications for at least four weeks prior to the screening visit
- Speak English as primary language
- Females of childbearing potential must have a negative urine pregnancy test at screening and agree to use contraception throughout the trial and for 30 days after last dose
Must NOT have:
- Received an investigational product in another clinical study during the last four weeks prior to screening
- Diagnosis of type 1 diabetes
- Diagnosis of type 2 diabetes treated with insulin, sulfonylureas, glucagon-like peptide 1 receptor agonists, thiazolidinedione, or sodium-glucose cotransporter-2 inhibitors (SGLT2); metformin monotherapy is allowed
- Estimated glomerular filtration rate less than 45 ml/min at screening or unstable kidney disease
- Inability to undergo MRI, such as a pacemaker or claustrophobia
- Severe live injury and/or significant abnormal liver function defined as aspartate aminotransferase and/or alanine aminotransferase greater than 3 times the upper limit of normal
- Total bilirubin more than 2.0 mg/dl (34.2 mol/L)
- Intolerance or allergy to dapagliflozin, other SGLT2 inhibitors, or other substance in the tablets
- Dementia due to causes other than Alzheimer's disease
- History of recurrent urinary tract infection
- Active mycotic (fungal) genital infection
- History of bladder cancer
- History of diabetic ketoacidosis
- Potentially confounding, serious, or unstable medical conditions such as cancer within the past three years (except basal cell, squamous cell, or localized prostate cancer), a recent cardiac event such as heart attack or angioplasty in past three months, or other conditions that pose a potential safety risk or could affect study results
- Significant abnormal results from physical examination, vital signs, or clinical laboratory tests
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Jeff Burns, MD
Source: ClinicalTrials.gov ID: NCT03801642