TY - JOUR
T1 - STAREE-Mind Imaging Study
T2 - a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals
AU - STAREE Investigator Group
AU - Harding, Ian H.
AU - Ryan, Joanne
AU - Heritier, Stephane
AU - Spark, Simone
AU - Flanagan, Zachary
AU - McIntyre, Richard
AU - Anderson, Craig S.
AU - Naismith, Sharon L.
AU - Chong, Trevor T.J.
AU - O'Sullivan, Michael
AU - Egan, Gary
AU - Law, Meng
AU - Zoungas, Sophia
AU - Beilin, Lawrence
AU - Chong, Trevor T.J.
AU - Cloud, Geoffrey C.
AU - Nicholls, Stephen J.
AU - Tonkin, Andrew
AU - Ward, Stephanie A.
AU - Wierzbicki, Anthony S.
AU - Zoungas, Sophia
AU - Curtis, Andrea J.
AU - Hopper, Ingrid
AU - Kost, Alissia
AU - McNeil, John J.
AU - Ryan, Joanne
AU - Spark, Simone
AU - Wolfe, Rory
AU - Simes, John
AU - Hankey, Graeme
AU - Richards, A. Mark
AU - Woodward, Mark
AU - Herschtal, Alan
AU - Le, Thao
N1 - Funding Information:
STAREE-Mind imaging is funded by the National Health and Medical Research Council (NHMRC, 2006611). The STAREE trial is sponsored by Monash University and has received funding from the NHMRC (grants 1068146 and 1161503), and a grant from the National Heart Foundation of Australia (HF Stroke Prevention grant). JR is supported by an NHMRC Leadership 1 Investigator Grant (2016438). SN is supported by an NHMRC Leadership 2 Investigator Grant (2008064). The funders have no role in the study design, collection, management, analysis and interpretation of data, nor in the writing of the publications. We acknowledge the contributions of Clare Berry, Lachlan Clyne, Tina Zacharis, Stephen Glanville and Jacqui Amadi to the implementation of these protocols at the research sites.
Publisher Copyright:
© Author(s) (or their employer(s)) 2023.
PY - 2023/10/31
Y1 - 2023/10/31
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85177424297&partnerID=8YFLogxK
U2 - 10.1136/bmjno-2023-000541
DO - 10.1136/bmjno-2023-000541
M3 - Article
C2 - 37920607
AN - SCOPUS:85177424297
SN - 2632-6140
VL - 5
JO - BMJ Neurology Open
JF - BMJ Neurology Open
IS - 2
M1 - e000541
ER -
