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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAREE Statin group | Experimental |
| |
| STAREE Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40 Mg Oral Tablet | Drug | 40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally |
|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Cortical thickness | Cortical thickness as measured by T1-weighted structural MRI. | Change from baseline to four years |
| Hippocampal volume | Change from baseline to four years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Zoungas, MBBS, FRACP | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herston Imaging Research Facility (HIRF) | Herston | Queensland | 4029 | Australia | ||
| Monash Biomedical Imaging (MBI) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920607 | Derived | Harding IH, Ryan J, Heritier S, Spark S, Flanagan Z, McIntyre R, Anderson CS, Naismith SL, Chong TT, O'Sullivan M, Egan G, Law M, Zoungas S. STAREE-Mind Imaging Study: a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals. BMJ Neurol Open. 2023 Oct 31;5(2):e000541. doi: 10.1136/bmjno-2023-000541. eCollection 2023. |
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After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.
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| Placebo | Drug | 2 x 20mg placebo (daily), taken orally. Identical appearance to study drug |
|
| Microbleeds and lacunae | Change from baseline to four years |
| Prefrontal cortex cerebral perfusion | Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI. | Change from baseline to four years |
| 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 |
| Peri-vascular space volume | From brain T1-weighted MRI | Change from baseline to four years |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| ID | Term |
|---|---|
| D000093902 | Mixed Dementias |
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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