Protocol development to study launch: The Australian‐multidomain approach to reduce dementia risk by protecting brain health With lifestyle intervention (AU‐ARROW) study
Authors: Fuller Stephanie Jane , Gardener Samantha L , Shah Tejal M , Naismith Sharon L , Baker Laura D , Kivipelto Miia , Sohrabi Hamid R , Thompson Belinda , Chen Juliana , Burnham Samantha C , Villemagne Victor L , Grieve Stuart , Yates Paul A , Raman Rema , Gleason Andrew , Ireland Catriona , Clarnette Roger , Taddei Kevin , Chatterjee Pratishtha , Brown Belinda M , Rainey‐Smith Stephanie , Hillebrandt Heidi L , Savage Greg , Steiner Genevieve Z. , Fripp Jurgen , Dore Vincent , England Tim , Kenny Peter , Peters Ruth , Anstey Kaarin J. , Martins Ralph N 
Published: June 2023

AbstractBackgroundThe Finnish Geriatric Intervention Study (FINGER) reported that a multidomain lifestyle intervention could provide an effective and accessible means of protecting against age‐related cognitive decline and dementia. This led to the global dementia risk reduction initiative: World‐Wide FINGERS (WW‐FINGERS). As part of WW‐FINGERS, the AU‐ARROW study mirrors aspects of FINGER, as well as the U.S. study (US‐POINTER, also part of WW‐FINGERS), while allowing for Australian cultural and dietary adaptations.MethodAU‐ARROW is a randomised, single‐blind, 2‐year clinical trial, recruiting 600 participants aged 60‐79, who satisfy study‐specific eligibility inclusion/exclusion criteria. Participants will be recruited at (a) Macquarie University, Sydney, NSW and (b) Sarich Neuroscience Research Institute, Edith Cowan University, Perth, WA, and randomised into either the multimodal lifestyle intervention (ML) group or the Health Education and Coaching (HC) group. The ML group will engage in a) aerobic exercise, resistance training and stretching facilitated by local gym memberships, b) monthly telehealth diet monitoring and advice, to encourage MIND diet adherence whilst aligning with Australian Dietary Guidelines, c) online BrainHQ cognitive training sessions, and d) medical monitoring and health education sessions. The HC group will receive occasional health education sessions. All participants receive heart rate trackers, 6‐monthly blood tests, regular health monitoring and clinician advice.ResultAU‐ARROW’s primary outcome measure involves assessment of changes in a global composite cognitive score, measured using neurocognitive tests as in US‐POINTER. Further neurocognitive tests, lifestyle questionnaires, physical function tests, diet and sleep monitoring will determine specific contributions of the various lifestyle changes. Extra value will emanate from Alzheimer’s disease (AD) biomarker analysis of blood and urine samples collected yearly, as well as AD Aβ amyloid‐specific ligand‐PET imaging, brain MRI and retinal biomarker tests at 0 and 24 months. The final AU‐ARROW protocol design and methods will be presented. Initial recruitment data may also be presented.ConclusionThe finalised AU‐ARROW protocol is expected to facilitate study completion and maximise data sources, and allow a) development of an evidence‐based innovative treatment plan to reduce cognitive decline and dementia risk, b) effective transfer of research outcomes into Australian health policy, and c) validation of emerging blood and retinal diagnostic biomarkers in preclinical screening.