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DECIST

UnknownPhase 2 / PHASE3

Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

Lead sponsor

Jaime Daniel Mondragon

Asset

Dapagliflozin

Listed sites

Recruiting sites

Enrollment

270

estimated

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age 60-80

Primary endpoint

•Clinical Dementia Rating score as a proxy of cognitive deterioration

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 IDF-2022-1005-016

NCT IDNCT05565976

Timeline

Milestones

Study start2020-08-01actual

Study first posted2022-10-04actual

Last update posted2022-10-04actual

Primary completion2024-12-31estimated

Study completion2025-07-01estimated

Assets

Drug assets

Dapagliflozin

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Ages of 60 and 80 years

•Both sexes

•Cerebrovascular ischemic event within 15 days

•Clinical dementia rating score ≤ 0.5

•Signed informed consent

Exclusion criteria

•Type 1 diabetes mellitus

•Aphasia

•Incomplete neuropsychological battery

•Previously diagnosed dementia

•Cerebrovascular ischemic stroke older than 15 days

•History of hemorrhagic cerebrovascular event

•Neoplasia diagnosis or evidence of a metastatic process, glomerular filtration rate < 45 mL/min at the time of inclusion

•Liver enzyme test alterations (i.e., aspartate transaminase or alanine transaminase three times greater than normal levels, total bilirubin> 2.0 mg/dL

•Previously taking SGLT2 inhibitors

•History of diabetic ketoacidosis

•Recurrent urinary tract infections

•Psychiatric disorders (e.g., dementia, psychosis, bipolar disorder, among others).

•Less than a 12-month follow-up

•Inability to perform chest CT (e.g., claustrophobia)

•Incomplete medical files pertaining to the variables of interest

•Less than 12-month follow-up

•Decision to withdraw their participation at any moment

•Poor adherence to medical treatment

•Reported and documented disease complications or adverse effects (e.g., severe glycemic imbalance, diabetic ketoacidosis, or hyperosmolar hyperglycemic state, altered hepatic enzyme tests)

Endpoints (3)

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)

Global cognition

1 endpoint

Primary/protocol endpoint

Change in Clinical Dementia Rating score as a proxy of cognitive deterioration

Time frame:6 and 12 months

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Number of strokes after initial cerebrovascular event

Time frame:12 months

event count, event

Other/protocol endpoint/low confidence

Adverse effects due to Dapagliflozin

Time frame:12 months

descriptive

Publications (22)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.