Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

Sponsor
Jaime Daniel Mondragon
Study ID
NCT05565976
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Dementia, Vascular
  • Metabolic Syndrome
  • Mild Cognitive Impairment
  • Stroke, Ischemic

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    10mg PO q24h for 12 months
  • Statins (Cardiovascular Agents) — DRUG
    Atorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h
  • Platelet Antiaggregant — DRUG
    Clopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h
  • Antidiabetic — DRUG
    Previously established medical treatment for type 2 diabetes will be maintained.

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
Oct 2022
Primary completion
Dec 31, 2024
Completion
Jul 1, 2025

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin
    10mg PO q24h for 12 months plus standard treatment with statins, platelet antiaggregant, and hypoglycemic medications.
  • Active Comparator: Standard treatment
    Standard treatment with statins, platelet antiaggregant, and hypoglycemic medications.

Primary Outcome Measure

Change in Clinical Dementia Rating score as a proxy of cognitive deterioration [ Time Frame: 6 and 12 months ]

Central Contacts

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