Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type, Cognitive Decline, White Matter Hyperintensity, Aging, Neuro-Degenerative Disease
Conditions
Keywords
White matter mean diffusivity, Perivascular space, Free water, White matter hyperintensity
Brief summary
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.
Detailed description
STAREE-Mind imaging is a sub-study nested in the Statins in Reducing Events in the Elderly (STAREE) double blind randomised placebo-controlled trial. STAREE is investigating whether statins can prolong good health and maintain independence amongst older people and is enrolling. STAREE-Mind imaging aims to recruit a sub-group of 340 participants, and will involve an additional suite of brain imaging in these participants, at recruitment (before medication is commenced) and at 4 years follow-up. It will provide crucial information about the clinical effects of statins on brain health in older individuals.
Interventions
40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally
DRUGPlacebo
2 x 20mg placebo (daily), taken orally. Identical appearance to study drug
Sponsors
National Health and Medical Research Council, Australia
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free water | Change from baseline to four years | Multi-compartment free water quantitation from brain diffusion-weighted MRI |
| White matter hyperintensity volume | Change from baseline to four years | From brain FLAIR MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbleeds and lacunae | Change from baseline to four years | — |
| Prefrontal cortex cerebral perfusion | Change from baseline to four years | Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI. |
| Cortical thickness | Change from baseline to four years | Cortical thickness as measured by T1-weighted structural MRI. |
| Peri-vascular space volume | Change from baseline to four years | From brain T1-weighted MRI |
| Whole-brain white matter fractional anisotropy | Change from baseline to four years | Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI. |
| Hippocampal volume | Change from baseline to four years | — |
Countries
Australia
Outcome results
None listed