drugset
drugset / Trial / NCT05565976

Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

NCT05565976 ↗

Phase 2/3 Unknown 270 enrolled Jaime Daniel Mondragon Hospital General León · collabHospital General de Zona IMSS N0. 21 · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2020-08-01
Primary completion
2024-12-31
Completion
2025-07-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral
Background Aspirin Small molecule 100 mg Oral
Background Atorvastatin Small molecule 20 mg Oral
Background Bromocriptine Small molecule — —
Background Clopidogrel Small molecule 75 mg Oral
Background Insulin Protein / enzyme biologic — —
Background Insulin Lispro Protein / enzyme biologic — —
Background Pravastatin Small molecule 20 mg Oral
Background Rosuvastatin Small molecule 10 mg Oral
Background insulin glargine Protein / enzyme biologic — —

Indications

cognitive impairment with or without cerebellar ataxia ischemic stroke metabolic syndrome X vascular dementia