Intervention for a Digital, Cognitive, Multi-Domain Alzheimer Risk Velocity Study: Protocol for a Randomized Controlled Trial

Abstract

Background In the United States, more than 6 million adults live with Alzheimer disease (AD) that affects 1 out of every 3 older adults. Although there is no cure for AD currently, lifestyle-based interventions aimed at slowing the rate of cognitive decline or delaying the onset of AD have shown promising results. However, most studies primarily focus on older adults (>55 years) and use in-person interventions. Objective The aim of this study is to determine the effects of a 2-year digital lifestyle intervention on AD risk among at-risk middle-aged and older adults (45-75 years) compared with a health education control. Methods The lifestyle intervention consists of a digitally delivered, personalized health coaching program that directly targets the modifiable risk factors for AD. The primary outcome measure is AD risk as determined by the Australian National University-Alzheimer Disease Risk Index; secondary outcome measures are functional fitness, blood biomarkers (inflammation, glucose, cholesterol, and triglycerides), and cognitive function (Repeatable Battery for the Assessment of Neuropsychological Status and Neurotrack Cognitive Battery). Screening commenced in January 2021 and was completed in June 2021. Results Baseline characteristics indicate no difference between the intervention and control groups for AD risk (mean −1.68, SD 7.31; P=.90). Conclusions The intervention in the Digital, Cognitive, Multi-domain Alzheimer Risk Velocity is uniquely designed to reduce the risk of AD through a web-based health coaching experience that addresses the modifiable lifestyle-based risk factors. Trial Registration ClinicalTrials.gov NCT04559789; https://clinicaltrials.gov/show/NCT04559789 International Registered Report Identifier (IRRID) DERR1-10.2196/31841