Skip to main content
Delfa

← Trials/Trial dossier/NCT03801642

CompletedPhase 1 / PHASE2Results posted

Dapagliflozin In Alzheimer's Disease

Randomized Controlled Pilot Trial Of Dapagliflozin In Alzheimer's Disease

Lead sponsor

Jeff Burns, MD

Asset

Dapagliflozin

Listed sites

1

Recruiting sites

-

Enrollment

46

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 15-26Study 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

Org study IDDapa in AD
NCT IDNCT03801642

Timeline

Milestones

Study first posted2019-01-11actual
Study start2019-01-29actual
Primary completion2022-07-07actual
Study completion2022-07-07actual
Last update posted2024-06-13actual
Results first posted2024-06-13actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
36
Global cognition
6
Neuroimaging
4
Safety / tolerability / PK
4
Memory
2

Global cognition

6 endpoints
Other/protocol endpoint

ADAS-Cog 14

Time frame:12 weeks

ADAS-Cog

descriptive

Other/protocol endpoint

Trailmaking B

Time frame:12 weeks

descriptive

Other/protocol endpoint

Stroop Word Color Test

Time frame:12 weeks

descriptive

Other_pre_specified/registry result

ADAS-Cog 14

Time frame:12 weeks

ADAS-Cog

descriptive

Other_pre_specified/registry result

Trailmaking B

Time frame:12 weeks

descriptive

Other_pre_specified/registry result

Stroop Word Color Test

Time frame:12 weeks

descriptive

Memory

2 endpoints
Other/protocol endpoint

Logical Memory II

Time frame:12 weeks

descriptive

Other_pre_specified/registry result

Logical Memory II

Time frame:12 weeks

descriptive

Neuroimaging

4 endpoints
Primary/protocol endpoint

Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine

Time frame:12 weeks

change from baseline, improvement

Primary/registry result

Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine

Time frame:12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), RatioStandard deviation
Dapagliflozinn=28 Participants1.490.11
Matching Placebon=15 Participants1.420.09
Other/protocol endpoint

FDG PET Metabolism (Standard Uptake Value Ratio)

Time frame:12 weeks

ratio, descriptive

Other_pre_specified/registry result

FDG PET Metabolism (Standard Uptake Value Ratio)

Time frame:12 weeks

ratio, descriptive

Safety / tolerability / PK

4 endpoints
Other/protocol endpoint

Number of Adverse Events

Time frame:14 weeks

event count, event

Other/protocol endpoint

Number of Discontinuations Due to Adverse Events

Time frame:14 weeks

event count, event

Other_pre_specified/registry result

Number of Adverse Events

Time frame:14 weeks

event count, event

Other_pre_specified/registry result

Number of Discontinuations Due to Adverse Events

Time frame:14 weeks

event count, event

Other (unclassified)

36 endpoints
Other/protocol endpoint/low confidence

Systemic NAA Levels

Time frame:12 weeks

concentration, descriptive

Other/protocol endpoint/low confidence

Total Cholesterol

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

LDL Cholesterol

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

HDL Cholesterol

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Plasma Beta-hydroxybutyrate

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Hemoglobin A1C

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Glucose Area Under the Curve

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Insulin Area Under the Curve

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Activated AKT Levels

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

MTOR Phosphorylation

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Platelet Cytochrome Oxidase Activity

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Monocyte Chemotactic Protein 1 (MCP-1)

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Eotaxin-1

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Tumor Necrosis Factor (TNF) - Alpha

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

C-Reactive Protein (CRP)

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Total Fat Mass

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Total Lean Mass

Time frame:12 weeks

descriptive

Other/protocol endpoint/low confidence

Resting Metabolic Rate

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Systemic NAA Levels

Time frame:12 weeks

concentration, descriptive

Other_pre_specified/registry result/low confidence

Total Cholesterol

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

LDL Cholesterol

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

HDL Cholesterol

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Plasma Beta-hydroxybutyrate

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Hemoglobin A1C

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Glucose Area Under the Curve

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Insulin Area Under the Curve

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Activated AKT Levels

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

MTOR Phosphorylation

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Platelet Cytochrome Oxidase Activity

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Monocyte Chemotactic Protein 1 (MCP-1)

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Eotaxin-1

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Tumor Necrosis Factor (TNF) - Alpha

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

C-Reactive Protein (CRP)

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Total Fat Mass

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Total Lean Mass

Time frame:12 weeks

descriptive

Other_pre_specified/registry result/low confidence

Resting Metabolic Rate

Time frame:12 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.