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

Samantha L Gardener; Stephanie J Fuller; Sharon L Naismith; Laura Baker; Miia Kivipelto; Victor L Villemagne; Stuart M Grieve; Paul Yates; Stephanie R Rainey-Smith; Juliana Chen; Belinda Thompson; Nicola J Armstrong; Malika G Fernando; Carolina Blagojevic Castro; Silochna Meghwar; Rema Raman; Andrew Gleason; Catriona Ireland; Roger Clarnette; Kaarin J Anstey; Kevin Taddei; Manohar Garg; Hamid R Sohrabi; Ralph N Martins

doi:10.1002/trc2.12466

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

Alzheimers Dement (N Y). 2024 Apr 9;10(2):e12466. doi: 10.1002/trc2.12466. eCollection 2024 Apr-Jun.

Authors

Samantha L Gardener^{1

2

3}, Stephanie J Fuller⁴, Sharon L Naismith⁵, Laura Baker⁶, Miia Kivipelto^{7

8}, Victor L Villemagne^{1

9

10}, Stuart M Grieve¹¹, Paul Yates¹⁰, Stephanie R Rainey-Smith^{1

2

3

12

13}, Juliana Chen^{4

14}, Belinda Thompson¹⁵, Nicola J Armstrong¹⁶, Malika G Fernando⁴, Carolina Blagojevic Castro^{2

13}, Silochna Meghwar⁴, Rema Raman¹⁷, Andrew Gleason^{4

18

19}, Catriona Ireland⁵, Roger Clarnette¹², Kaarin J Anstey²⁰, Kevin Taddei¹, Manohar Garg⁴, Hamid R Sohrabi^{1

2

4

13}, Ralph N Martins^{1

2

4

13}

Affiliations

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

Introduction: The 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.

Method: AU-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.

Discussion: The 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.

Keywords: Alzheimer's disease; Australia; brain health; dementia; multidomain lifestyle intervention; randomized controlled trial; study protocol.