Effect of Dapagliflozin on Cognitive Impairment after Stroke
Dapagliflozin Effect in Cognitive Impairment in Stroke Trial
This study tests if the medication dapagliflozin can improve thinking skills in people aged 60 to 80 who have had a stroke.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Universidad de Guanajuato Academic / other |
| Locations | 1 site (León, Guanajuato) |
| Trial ID | NCT05565976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of dapagliflozin on cognitive function in patients aged 60 to 80 who have recently experienced an ischemic stroke. It is a double-blind, randomized, placebo-controlled study conducted over 12 months at a single center in León, Mexico, involving 270 participants. The study aims to assess cardiovascular risk factors and cognitive outcomes in individuals with mild cognitive impairment following a stroke. Participants will be randomly assigned to receive either dapagliflozin or a placebo, with various statistical analyses planned to evaluate the results.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 to 80 who have had an ischemic stroke within the last 15 days and have a clinical dementia rating score of 0.5 or lower.
Not a fit: Patients with a history of dementia, type 1 diabetes, or significant renal or liver issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to improve cognitive function and reduce cardiovascular risks in stroke patients.
How similar studies have performed: While the specific use of dapagliflozin for cognitive impairment post-stroke is novel, similar studies have shown promise in using SGLT2 inhibitors for various metabolic and cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
León, Guanajuato
- Hospital General de Zona IMSS 21 — León, Guanajuato, Mexico (Recruiting)
Study contacts
- Principal investigator: Jaime D Mondragón, M.D., Ph.D. — University Medical Center Groningen, Department of Neurology, Alzheimer Center Groningen
- Study coordinator: Omar Jiménez-Zarazúa, M.D.
- Email: drzarazuainterna@hotmail.com
- Phone: +524423421626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.