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

A Novel Digital Digit-Symbol Substitution Test Measuring Processing Speed in Adults At Risk for Alzheimer Disease: Validation Study

“…Specifically, raw scores were calculated as the number of correct responses given in 2 minutes. Data for this study were collected as part of an ongoing parent study (Digital Cognitive Multi-domain Alzheimer’s Risk Velocity [DC MARVel] Study) that is longitudinally examining changes in cognition and AD risk measures in at-risk adults randomized into either a health education or health-coaching intervention [ 17 ]. Further information regarding other subtests found in the Neurotrack Digital Testing Platform can be found in the published protocol for the DC MARVel Study [ 17 ].…”

Digital 2-year multidomain health interventions improve cognition and stabilize Alzheimer’s disease risk in at-risk adults (DC-MARVEL): A randomized controlled trial

“…Pursuant to planned ancillary studies administered concurrently with DC-MARVEL, additional in-person data collection took place during this study, but those elements are not relevant to the core methodology presented here. The published protocol for this study describes those ancillary protocol components in detail 21 .…”

“…To meet the inclusion criteria for this study, a participant had to be between the ages of 45 and 75 years, be uent in English, own a smartphone, be willing to communicate via text message, and have at least two of the following risk factors for ADRD based on the Australian National University-Alzheimer's disease risk index (ANU-ADRI) 22 : high school education or less; a body mass index (BMI) ≥ 25 kg/m 2 but less than 40 kg/m 2 ; or history of diabetes, hypertension, high cholesterol, smoking, or traumatic brain injury. Exclusion criteria were visual problems impacting the ability to view a screen at a normal distance; history of a learning disability; recent cardiovascular event; current participation in a cognitive training intervention or lifestyle change program; current diagnosis of any mental health condition, neurologic condition, dementia, mild cognitive impairment, or any other serious health condition; or more than one of the following ADRD protective factors based on the ANU-ADRI: high physical activity level, eating non-fried sh or seafood more than 5 times per week, or a high level of cognitive engagement 10,21 .…”

“…DC-MARVEL was evaluated and approved as an ethical research study by the Institutional Review Board at the University of Arkansas (Protocol Number: 2009280813A009), and the NIA's Data and Safety Monitoring Board provided ongoing safety and regulatory oversight. The study protocol 21 and preliminary analyses from four months of intervention 10 were published previously.…”

Perioperative Brain Health in the Older Adult: A Patient Safety Imperative

“…Cognitive testing and web-based products that improve long-term cognitive health through coaching experiences for the population at large are in development. 92 Specific to the perioperative period, tools have been developed with the goal of delivering end-toend digital health platforms that are accessible to the perioperative care team. These tools [93][94][95][96] introduce indepth neuropsychological tests in a time-efficient manner with minimal barriers to implementation, and are reported to be eligible for reimbursement by payors.…”