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Dapagliflozin In Alzheimer's Disease
Randomized Controlled Pilot Trial Of Dapagliflozin In Alzheimer's Disease
Lead sponsor
Asset
Dapagliflozin
Listed sites
1
Recruiting sites
-
Enrollment
46
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 15-26•Study partner/caregiver required
Primary endpoint
•Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures.
2. Have a diagnosis of probable AD per McKhann et al. criteria
3. Have a body mass index (BMI) ≥23
4. Age 50-85
5. Have a Mini Mental Status Exam (MMSE) score of 15-26 (inclusive) at screening visit
6. 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
7. Are on stable doses of concurrent medications for at least 4 weeks prior to the screening visit
8. Speaks English as his/her primary language.
9. 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 criteria
1. Received an investigational product in another clinical study during the last 4 weeks prior to screening
2. Diagnosis of Type 1 diabetes
3. 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).
4. Estimated Glomerular Filtration Rate (eGFR; MDRD) <45 mL/min at screening or unstable renal disease.
5. Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia.
6. 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)
7. Intolerance or allergy to dapaglifozin or any other SGLT2 inhibitor or any other substance in the tablets.
8. Dementia due to causes other than AD
9. History of recurrent urinary tract infection
10. Active mycotic genital infection
11. History of bladder cancer
12. History of diabetic ketoacidosis
13. Potentially confounding, serious, or unstable medical conditions such as:
1. cancer within the past 3 years (except basal cell, squamous cell, or localized prostate cancer)
2. a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 3 months prior to screening visit)
3. other conditions that pose a potential safety risk or confounding factor in the investigator's opinion
14. Any abnormal physical examination assessment or vital sign assessment at the screening visit that is deemed to be clinically significant by the principal investigator.
15. Any abnormal clinical laboratory test result at the screening visit that is deemed to be clinically significant by the principal investigator.
Endpoints (52)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
6 endpointsADAS-Cog 14
Time frame:12 weeks
ADAS-Cog
descriptive
Trailmaking B
Time frame:12 weeks
descriptive
Stroop Word Color Test
Time frame:12 weeks
descriptive
ADAS-Cog 14
Time frame:12 weeks
ADAS-Cog
descriptive
Trailmaking B
Time frame:12 weeks
descriptive
Stroop Word Color Test
Time frame:12 weeks
descriptive
Memory
2 endpointsLogical Memory II
Time frame:12 weeks
descriptive
Logical Memory II
Time frame:12 weeks
descriptive
Neuroimaging
4 endpointsRatio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine
Time frame:12 weeks
change from baseline, improvement
Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine
Time frame:12 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), Ratio | Standard deviation |
|---|---|---|
| Dapagliflozinn=28 Participants | 1.49 | 0.11 |
| Matching Placebon=15 Participants | 1.42 | 0.09 |
FDG PET Metabolism (Standard Uptake Value Ratio)
Time frame:12 weeks
ratio, descriptive
FDG PET Metabolism (Standard Uptake Value Ratio)
Time frame:12 weeks
ratio, descriptive
Safety / tolerability / PK
4 endpointsNumber of Adverse Events
Time frame:14 weeks
event count, event
Number of Discontinuations Due to Adverse Events
Time frame:14 weeks
event count, event
Number of Adverse Events
Time frame:14 weeks
event count, event
Number of Discontinuations Due to Adverse Events
Time frame:14 weeks
event count, event
Other (unclassified)
36 endpointsSystemic NAA Levels
Time frame:12 weeks
concentration, descriptive
Total Cholesterol
Time frame:12 weeks
descriptive
LDL Cholesterol
Time frame:12 weeks
descriptive
HDL Cholesterol
Time frame:12 weeks
descriptive
Plasma Beta-hydroxybutyrate
Time frame:12 weeks
descriptive
Hemoglobin A1C
Time frame:12 weeks
descriptive
Glucose Area Under the Curve
Time frame:12 weeks
descriptive
Insulin Area Under the Curve
Time frame:12 weeks
descriptive
Activated AKT Levels
Time frame:12 weeks
descriptive
MTOR Phosphorylation
Time frame:12 weeks
descriptive
Platelet Cytochrome Oxidase Activity
Time frame:12 weeks
descriptive
Monocyte Chemotactic Protein 1 (MCP-1)
Time frame:12 weeks
descriptive
Eotaxin-1
Time frame:12 weeks
descriptive
Tumor Necrosis Factor (TNF) - Alpha
Time frame:12 weeks
descriptive
C-Reactive Protein (CRP)
Time frame:12 weeks
descriptive
Total Fat Mass
Time frame:12 weeks
descriptive
Total Lean Mass
Time frame:12 weeks
descriptive
Resting Metabolic Rate
Time frame:12 weeks
descriptive
Systemic NAA Levels
Time frame:12 weeks
concentration, descriptive
Total Cholesterol
Time frame:12 weeks
descriptive
LDL Cholesterol
Time frame:12 weeks
descriptive
HDL Cholesterol
Time frame:12 weeks
descriptive
Plasma Beta-hydroxybutyrate
Time frame:12 weeks
descriptive
Hemoglobin A1C
Time frame:12 weeks
descriptive
Glucose Area Under the Curve
Time frame:12 weeks
descriptive
Insulin Area Under the Curve
Time frame:12 weeks
descriptive
Activated AKT Levels
Time frame:12 weeks
descriptive
MTOR Phosphorylation
Time frame:12 weeks
descriptive
Platelet Cytochrome Oxidase Activity
Time frame:12 weeks
descriptive
Monocyte Chemotactic Protein 1 (MCP-1)
Time frame:12 weeks
descriptive
Eotaxin-1
Time frame:12 weeks
descriptive
Tumor Necrosis Factor (TNF) - Alpha
Time frame:12 weeks
descriptive
C-Reactive Protein (CRP)
Time frame:12 weeks
descriptive
Total Fat Mass
Time frame:12 weeks
descriptive
Total Lean Mass
Time frame:12 weeks
descriptive
Resting Metabolic Rate
Time frame:12 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.