Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy

Conditions
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Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type, Cognitive Decline, White Matter Hyperintensity, Aging, Neuro-Degenerative Disease

Intervention / Treatment
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* Drug: Atorvastatin 40 Mg Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAREE Statin group<br> | Drug: Atorvastatin 40 Mg Oral Tablet<br>* 40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally<br>|
| Placebo Comparator: STAREE Placebo group<br> | Drug: Placebo<br>* 2 x 20mg placebo (daily), taken orally. Identical appearance to study drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free water | Multi-compartment free water quantitation from brain diffusion-weighted MRI | Change from baseline to four years | 
| White matter hyperintensity volume | From brain FLAIR MRI | Change from baseline to four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White matter mean diffusivity, Perivascular space, Free water, White matter hyperintensity