Dapagliflozin Effect in Cognitive Impairment in Stroke Trial
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Jaime Daniel Mondragon
Collaborators:
Hospital General de Zona IMSS N0. 21 Hospital General León University Medical Center Groningen