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)
- Conditions
- Cognitive decline in older adultsNeurological - Studies of the normal brain and nervous system
- Registration Number
- ACTRN12609000613202
- Lead Sponsor
- Australian National University (ANU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 600
All subjects will be aged 70 years or more and capable of attending their usual family physician's clinic, providing informed consent and have no known contraindications to MRI.
1. A history of cardiovascular morbidity defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, greater than 50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, or coronary artery bypass grafting
2. A serious intercurrent illness likely to cause death within the next 5 years
3. A current or recurrent condition with a high risk of major bleeding e.g. cerebral aneurysm or cerebral arteriovenous (AV) malformation, any bleeding diathesis, gastrointestinal malignancy, peptic ulcer, liver disease, uraemia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding
4. Absolute contraindication or allergy to aspirin
5. Current participation in a clinical trial
6. Current continuous use of aspirin or other anti-platelet drug or anticoagulant
7. A history of dementia
8. In addition those who lie outside of tolerance levels of 8-104% during placebo run-in phase will not be randomised
9. An inability to perform independently one of the 6 Katz Activities of Daily Living (walking, bathing, dressing, transferring from chair or bed, toileting, eating)
10. Pill taking compliance below 80% on tablet count during a placebo run-in phase
11. Absolute contraindications to undergo MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in brain magnetic resonance imaging (MRI) including white matter hyper intensity (WMH) and silent brain infarction (SBI) volumes.[3 years following randomisation];Changes in retinal vascular imaging (RVI) parameters, including quantitatively measured retinal arteriolar and venular calibre and the presence of retinal arteriolar pathology.[3 years following randomisation]
- Secondary Outcome Measures
Name Time Method