Prevention of Dementia by Intensive Vascular Care - MRI sub-study
- Conditions
- cognitive declinedementia10007963
- Registration Number
- NL-OMON36576
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Elderly subjects aged 72-80 with no dementia and a systolic blood pressure above 140 mmHg
Exclusion Criteria
Dementia, limited life-expectancy due to any medical condition
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome parameters of this study are radiological. Increase in<br /><br>cerebrovascular lesions over a 4-year interval will be scored by raters blinded<br /><br>to any clinical information including the treatment allocation in the<br /><br>preDIVA-trial.<br /><br><br /><br>- White matter lesion progression using visual rating scales, as well as<br /><br>volumetric analysis.<br /><br><br /><br>- Presence of cerebral infarcts at baseline and occurrence of new cerebral<br /><br>infarcts during the 4-year follow-up. Infarcts will be counted on baseline and<br /><br>follow-up scans.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br><br /><br>- Progression of hippocampal atrophy and global cerebral atrophy, using both<br /><br>visual rating scales as well as volumetric analysis.<br /><br>- Correlation of progression of cerebrovascular lesions with clinical data from<br /><br>the preDIVA-trial, such as vascular risk factors.<br /><br>- Correlation of progression of cerebrovascular lesions with clinimetrical<br /><br>information which is collected in the preDIVA-trial, including cognitive<br /><br>testing and handicap. </p><br>