An Online, Person-Centered, Risk Factor Management Program to Prevent Cognitive Decline: Protocol for A Prospective Behavior-Modification Blinded Endpoint Randomized Controlled Trial

Yen Ying Lim, Darshini R Ayton, Stephanie Perin, Alex Lavale, Nawaf Yassi, Rachel Buckley, Chris Barton, Loren Burns Jr, Renata Morello, Stephanie Pirotta, Emily Rosenich, Shanthakumar Wilson Rajaratnam, Richard Sinnott, Amy Brodtmann, Ashley I. Bush, Paul Maruff, Leonid Churilov, Anna Barker, Matthew Pase, on behalf of the BetterBrains Research Group

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Background: Several modifiable risk factors for dementia have been identified, although the extent to which their modification leads to improved cognitive outcomes remains unclear. Objective: The primary aim is to test the hypothesis that a behavior modification intervention program targeting personalized risk factors prevents cognitive decline in community-dwelling, middle-aged adults with a family history of dementia. Methods: This is a prospective, risk factor management, blinded endpoint, randomized, controlled trial, where 1510 cognitively normal, community-dwelling adults aged 40-70 years old will be recruited. Participants will be screened for risk factors related to vascular health (including physical inactivity), mental health, sleep, and cognitive/social engagement. The intervention is an online person-centered risk factor management program: BetterBrains. Participants randomized to intervention will receive telehealth-based person-centered goal setting, motivational interviewing, and follow-up support, health care provider communication and community linkage for management of known modifiable risk factors of dementia. Psychoeducational health information will be provided to both control and intervention groups. Results: The primary outcome is favorable cognitive performance at 24-months post-baseline, defined as the absence of decline on one or more of the following cognitive tests: (a) Cogstate Detection, (b) Cogstate One Card Learning, (c) Cogstate One Back, and (d) Cognitive Function Instrument total score. Conclusion: We will test the hypothesis that the BetterBrains intervention program can prevent cognitive decline. By leveraging existing community services and using a risk factor management pathway that tailors the intervention to each participant, we maximize likelihood for engagement, long-term adherence, and for preserving cognitive function in at-risk individuals.

Original languageEnglish
Pages (from-to)1603-1622
Number of pages20
JournalJournal of Alzheimer's Disease
Issue number4
Publication statusPublished - 12 Oct 2021


  • Alzheimer's disease
  • clinical trial
  • cognitive decline
  • dementia
  • lifestyle intervention
  • non-pharmacological
  • randomized control trial

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