The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU‐ARROW): A study protocol for a single‐blind, multi‐site, randomized controlled trial

Author:

Gardener Samantha L.123ORCID,Fuller Stephanie J.4,Naismith Sharon L.5,Baker Laura6,Kivipelto Miia78,Villemagne Victor L.1910,Grieve Stuart M.11,Yates Paul10,Rainey‐Smith Stephanie R.1231213,Chen Juliana414,Thompson Belinda15,Armstrong Nicola J.16,Fernando Malika G.4,Blagojevic Castro Carolina213,Meghwar Silochna4,Raman Rema17,Gleason Andrew41819,Ireland Catriona5,Clarnette Roger12,Anstey Kaarin J.20,Taddei Kevin1,Garg Manohar4,Sohrabi Hamid R.12413,Martins Ralph N.12413

Affiliation:

1. Centre of Excellence for Alzheimer's Disease Research and Care School of Medical and Health Sciences Edith Cowan University Joondalup Western Australia Australia

2. Alzheimer's Research Australia Ralph and Patricia Sarich Neuroscience Research Institute Nedlands Western Australia Australia

3. Lifestyle Approaches Towards Cognitive Health Research Group Murdoch University Murdoch Western Australia Australia

4. Department of Biomedical Sciences Macquarie University Sydney New South Wales Australia

5. The University of Sydney Sydney New South Wales Australia

6. Wake Forest University School of Medicine Winston‐Salem North Carolina USA

7. Karolinska Institutet Solna Stockholm Sweden

8. FINGERS Brain Health Institute Stockholm Sweden

9. University of Pittsburgh Pittsburgh Pennsylvania USA

10. Austin Health, Department of Nuclear Medicine and Centre for Positron Emission Tomography Heidelberg Victoria Australia

11. Imaging and Phenotyping Laboratory, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney Sydney New South Wales Australia

12. The University of Western Australia Perth Western Australia Australia

13. Centre for Healthy Ageing Murdoch University Murdoch Western Australia Australia

14. Discipline of Nutrition and Dietetics Susan Wakil School of Nursing and Midwifery Charles Perkins Centre The University of Sydney Sydney New South Wales Australia

15. Department of Health Sciences Australian Lymphoedema Education Research and Treatment Macquarie University Sydney New South Wales Australia

16. Curtin University Bentley Western Australia Australia

17. Alzheimer's Therapeutic Research Institute University of Southern California San Diego California USA

18. Florey Institute of Neuroscience and Mental Health University of Melbourne Parkville Victoria Australia

19. Department of Neuroscience Central Clinical School The Alfred Centre Monash University Victoria Australia

20. University of New South Wales Sydney New South Wales Australia

Abstract

AbstractINTRODUCTIONThe Finnish Geriatric Intervention Study (FINGER) led to the global dementia risk reduction initiative: World‐Wide FINGERS (WW‐FINGERS). As part of WW‐FINGERS, the Australian AU‐ARROW study mirrors aspects of FINGER, as well as US‐POINTER.METHODAU‐ARROW is a randomized, single‐blind, multisite, 2‐year clinical trial (n = 600; aged 55–79). The multimodal lifestyle intervention group will engage in aerobic exercise, resistance training and stretching, dietary advice to encourage MIND diet adherence, BrainHQ cognitive training, and medical monitoring and health education. The Health Education and Coaching group will receive occasional health education sessions. The primary outcome measure is the change in a global composite cognitive score. Extra value will emanate from blood biomarker analysis, positron emission tomography (PET) imaging, brain magnetic resonance imaging (MRI), and retinal biomarker tests.DISCUSSIONThe finalized AU‐ARROW protocol is expected to allow development of an evidence‐based innovative treatment plan to reduce cognitive decline and dementia risk, and effective transfer of research outcomes into Australian health policy.Highlights Study protocol for a single‐blind, randomized controlled trial, the AU‐ARROW Study. The AU‐ARROW Study is a member of the World‐Wide FINGERS (WW‐FINGERS) initiative. AU‐ARROW's primary outcome measure is change in a global composite cognitive score. Extra significance from amyloid PET imaging, brain MRI, and retinal biomarker tests. Leading to development of an innovative treatment plan to reduce cognitive decline.

Funder

National Health and Medical Research Council

Publisher

Wiley

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