Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Given its high worldwide prevalence and probable underdiagnosis, the international guidelines for the assessment of dementia syndromes recommend the assessment of cognitive impairment in patients over 55 years of age as part of clinical practice in patients who presented an ischemic cerebrovascular event. Several risk factors associated with cognitive impairment in cerebrovascular disease are identified in the literature: 1) demographic factors (e.g., age over 65 years and female sex); 2) risk factors present prior to the ischemic stroke (e.g., cognitive impairment, physical impairment); 3) factors utilized to assess the severity of an ischemic stroke (e.g., supratentorial location, ischemic stroke in the dominant hemisphere, recurrence of ischemic strokes); 4) post-ischemic stroke factors (e.g., delirium and seizures); and 5) factors associated with neuroimaging findings (e.g., cerebral small vessel disease, cortical atrophy, and medial temporal lobe atrophy).

This is a randomized controlled trial in individuals with an acute ischemic stroke without dementia that will be treated with 10mg dapagliflozin PO q24h for 12 months and standard treatment against only standard treatment (i.e., statins, platelet antiaggregant, and hypoglycemic medications) when appropriate. The outcome measure evaluated will be global cognitive function. Cardiovascular risk factors will be associated with cognitive decline.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaime Daniel Mondragon
• Collaborators: Hospital General de Zona IMSS N0. 21; Hospital General León; University Medical Center Groningen
• Treatments: 2,4-thiazolidinedione; Aspirin; Atorvastatin; Biguanides; Clopidogrel; Dapagliflozin; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Meglitinide; Platelet Aggregation Inhibitors; Pravastatin; Rosuvastatin Calcium

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)