Aging Clinical Trial
— STAREE-MindOfficial title:
Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
Verified date | July 2023 |
Source | Monash University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The STAREE-Mind imaging sub-study will examine the effect of statin treatment over a 4-year period, compared with placebo, on markers of brain health.
Status | Active, not recruiting |
Enrollment | 341 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - Participants in the STAREE RCT and eligible for randomisation to study medication. - Men and women - Aged =70 years - Living independently in the community - Willing and able to provide informed consent and agree to participate in brain neuroimaging. - Able to attend one of the 2 sites (in Melbourne and Brisbane) where the imaging will take place. Exclusion Criteria: - Contraindications to have magnetic resonance neuroimaging performed. - History of invasive brain surgery or known structural bran abnormalities. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Biomedical Imaging (MBI) | Clayton | Victoria |
Australia | Herston Imaging Research Facility (HIRF) | Herston | Queensland |
Lead Sponsor | Collaborator |
---|---|
Monash University | National Health and Medical Research Council, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cortical thickness | Cortical thickness as measured by T1-weighted structural MRI. | Change from baseline to four years | |
Other | Hippocampal volume | Change from baseline to four years | ||
Other | Microbleeds and lacunae | Change from baseline to four years | ||
Other | Prefrontal cortex cerebral perfusion | Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI. | Change from baseline to four years | |
Other | Whole-brain white matter fractional anisotropy | Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI. | Change from baseline to four years | |
Other | Peri-vascular space volume | From brain T1-weighted MRI | Change from baseline to four years | |
Primary | Free water | Multi-compartment free water quantitation from brain diffusion-weighted MRI | Change from baseline to four years | |
Primary | White matter hyperintensity volume | From brain FLAIR MRI | Change from baseline to four years |
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