Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

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.

Conditions

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

Interventions

DRUG

Dapagliflozin 10mg Tab

10mg PO q24h for 12 months

DRUG

Statins (Cardiovascular Agents)

Atorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h

DRUG

Platelet Antiaggregant

Clopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h

DRUG

Antidiabetic

Previously established medical treatment for type 2 diabetes will be maintained.

Sponsors & Collaborators

• Hospital General León

  collaborator UNKNOWN

• Hospital General de Zona IMSS N0. 21

  collaborator UNKNOWN

• University Medical Center Groningen

  collaborator OTHER

• Jaime Daniel Mondragon

  lead OTHER

Principal Investigators

• Gabriela G López-Hernández, M.D. · Hospital General de Zona IMSS 21

• Lizeth C Ramírez-Zamudio, M.D. · Hospital General de Zona IMSS 21

• Jaime D Mondragón, M.D., Ph.D. · University Medical Center Groningen, Department of Neurology, Alzheimer Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2024-12-31

Completion

2025-07-01

FDA Drug

Yes

Countries

• Mexico

Study Locations