| Title: |
STAREE-Mind Imaging Study: a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals |
| Authors: |
Harding, IH; Ryan, J; Heritier, S; Spark, S; Flanagan, Z; McIntyre, R; Anderson, CS; Naismith, SL; Chong, TTJ; O'Sullivan, M; Egan, G; Law, M; Zoungas, S; Beilin, L; Cloud, GC; Nicholls, SJ; Tonkin, A; Ward, SA; Wierzbicki, AS; Curtis, AJ; Hopper, I; Kost, A; McNeil, JJ; Nelson, MR; Reid, CM; Wolfe, R; Simes, J; Hankey, G; Richards, AM; Woodward, M; Herschtal, A; Le, T |
| Source: |
urn:ISSN:2632-6140 ; BMJ Neurology Open, 5, 2, e000541 |
| Publisher Information: |
BMJ |
| Publication Year: |
2023 |
| Collection: |
UNSW Sydney (The University of New South Wales): UNSWorks |
| Subject Terms: |
32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; Aging; Biomedical Imaging; Cerebrovascular; Behavioral and Social Science; Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD); Acquired Cognitive Impairment; Clinical Trials and Supportive Activities; Neurodegenerative; Neurosciences; Vascular Cognitive Impairment/Dementia; Alzheimer's Disease; Dementia; Alzheimer's Disease Related Dementias (ADRD); Brain Disorders; Clinical Research; Prevention; 6.1 Pharmaceuticals; Neurological; Cardiovascular; MRI; image analysis; neuroradiology; anzsrc-for: 32 Biomedical and Clinical Sciences; anzsrc-for: 3202 Clinical Sciences; anzsrc-for: 3209 Neurosciences; anzsrc-for: 4206 Public health |
| Description: |
Introduction Cerebrovascular disease and neurodegeneration are causes of cognitive decline and dementia, for which primary prevention options are currently lacking. Statins are well-tolerated and widely available medications that potentially have neuroprotective effects. The STAREE-Mind Imaging Study is a randomised, double-blind, placebo-controlled clinical trial that will investigate the impact of atorvastatin on markers of neurovascular health and brain atrophy in a healthy, older population using MRI. This is a nested substudy of the ‘Statins for Reducing Events in the Elderly’ (STAREE) primary prevention trial. Methods Participants aged 70 years or older (n=340) will be randomised to atorvastatin or placebo. Comprehensive brain MRI assessment will be undertaken at baseline and up to 4 years follow-up, including structural, diffusion, perfusion and susceptibility imaging. The primary outcome measures will be change in brain free water fraction (a composite marker of vascular leakage, neuroinflammation and neurodegeneration) and white matter hyperintensity volume (small vessel disease). Secondary outcomes will include change in perivascular space volume (glymphatic drainage), cortical thickness, hippocampal volume, microbleeds and lacunae, prefrontal cerebral perfusion and white matter microstructure. Ethics and dissemination Academic publications from this work will address the current uncertainty regarding the impact of statins on brain structure and vascular integrity. This study will inform the utility of repurposing these well-tolerated, inexpensive and widely available drugs for primary prevention of neurological outcomes in older individuals. Ethics approval was given by Monash University Human Research Ethics Committee, Protocol 12206. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
https://hdl.handle.net/1959.4/103447 |
| DOI: |
10.1136/bmjno-2023-000541 |
| Availability: |
https://hdl.handle.net/1959.4/103447; https://unsworks.unsw.edu.au/bitstreams/41e74b4d-1f33-4eee-a64e-196b303b926a/download; https://doi.org/10.1136/bmjno-2023-000541 |
| Rights: |
open access ; https://purl.org/coar/access_right/c_abf2 ; CC BY-NC ; https://creativecommons.org/licenses/by-nc/4.0/ ; free_to_read |
| Accession Number: |
edsbas.6D871736 |
| Database: |
BASE |