ActivePhase 4ACTRN12609000613202

Aspirin for the prevention of cognitive decline in the Elderly: a Neuro-Vascular Imaging Study (ENVIS-ion), a sub-study of ASPirin in Reducing Events in the Elderly (ASPREE)

A multi-centre, randomised, double-blind, placebo controlled trial of the effects of 100mg enteric-coated aspirin on rate of increase of magnetic resonance imaging(MRI)-based white matter hyperintensity (WMH) and silent brain infarction (SBI).


Sponsor

Australian National University (ANU)

Enrollment

600 participants

Start Date

Apr 27, 2010

Study Type

Interventional

Conditions

Summary

The ENVIS-ion trial will examine whether low dose aspirin is effective in delaying the onset of declining abilities of thinking and memory in healthy older adults. Participants in the ENVIS-ion trial will be recruited from men and women who have agreed and consented to participate in the clinical trial of low dose aspirin (the ASPREE Trial ISRCTN83772183). The main features of the ENVIS-ion trial are additional measurement of brain and retinal structures by magnetic resonance imaging (MRI) and retinal photography in each participant before starting on the study drug and after treatment with aspirin or placebo for 3 years. As a part of the ASPREE study, mental functions are assessed every year by questionnaires administered by a trained researcher. For ENVIS-ion, participants will have extra questionnaires to further test their mental abilities. MRI of brain structure will detect markers of early worsening of thinking and memory abilities. Blood vessels of the retina share many features with vessels of the brain. We will compare whether aspirin lessens changes over time of features shown with brain MRI and retinal photography and compare these with the questionnaire measurements of mental function.


Eligibility

Sex: Both males and femalesMin Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study examines whether low-dose aspirin can help prevent age-related mental decline and changes in brain blood vessels. It is for people aged 70 and over who have no history of heart disease, stroke, dementia, or serious bleeding problems, and who are able to undergo MRI scans.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Acetylsalicylic acid (aspirin) 100 mg; enteric coated unscored white tablet taken once per day for an average of 3 years

Acetylsalicylic acid (aspirin) 100 mg; enteric coated unscored white tablet taken once per day for an average of 3 years


Locations(2)

The Canberra Hospital - Garran

ACT,NSW,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

ACT,NSW,VIC, Australia

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ACTRN12609000613202