Reducing Dementia Risk With Digital Health Coaching

Not Applicable

• Conditions: Alzheimer Disease; Dementia; Cognitive Decline; Mild Cognitive Impairment
• Interventions: Behavioral: MindMate + Health Coaching; Other: Health Education

• Registration Number: NCT04559789
• Lead Sponsor: Neurotrack Technologies, Inc.

Brief Summary

The Digital Cognitive Multi-domain Alzheimer's Risk Velocity (DC MARVEL) study is a 2-year randomized controlled trial on dementia prevention. The purpose of this study is to determine the effect of a digital cognitive health program on dementia risk, cognitive function, and general health outcomes in middle age to older adults compared to a control group that receives health education.

Detailed Description

Alzheimer's Disease (AD) is expected to affect 131 million people worldwide by 2050, but as many as 40% of these cases may be prevented by targeting modifiable risk factors such as diet, physical activity, cognitive engagement, and smoking. Neurotrack Technologies, Inc. will test the efficacy of a digital multi-domain lifestyle intervention with health coaching for cognitive health designed to change behaviors associated with increased risk for AD. This digital intervention addresses the challenge of scaling effective multi-domain lifestyle interventions for cognitive health and has the potential to improve risk behaviors, thereby reducing and/or delaying cognitive decline in older adults at risk for AD.

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Study Start: 2021-01-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 45-75
• BMI 18.5 - 39.9 kg/m2
• Fluent in English (written and spoken)
• A minimum of 2 of the following risk factors for AD from ANU-ADRI: High school education or less; Overweight, or class I or class II obese (BMI 25-39.9 kg/m2); History of diabetes; History of hypertension; History of high cholesterol; History of smoking; History of traumatic brain injury
• Maximum of 1 of the following protective factors for AD from ANU-ADRI: High level of physical activity; High fish consumption; High level of cognitive engagement
• Ability to send and receive text messages
• Own a smartphone, have a reliable internet connection, and willing to use email
• Ability to participate in light to moderate physical activity
• Willingness to be randomized

Exclusion Criteria

• Physician diagnosis of: mental health condition (e.g., eating disorder, alcohol/substance use, schizophrenia, etc.); neurologic conditions (e.g. epilepsy, stroke, multiple sclerosis, Parkinson's disease, brain tumor, or severe traumatic brain injury); dementia, probable dementia, or mild cognitive impairment; other significant health condition (e.g. congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, renal failure, chronic kidney disease, pulmonary hypertension)
• Recent cardiovascular event or recent treatment for cancer (within the last year); on dialysis; or on active organ transplant list
• Visual problems that prevent viewing screen at a normal distance (e.g., legal blindness, detached retina, occlusive cataracts)
• History of learning disability
• Currently participating in a formal cognitive training coaching program or other lifestyle change program (e.g. diabetes prevention program)
• Currently pregnant or planning on becoming pregnant in the next two years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Lifestyle Intervention	MindMate + Health Coaching	Participants randomized to the intervention arm will receive access to a digital intervention consisting of the MindMate cognitive health app and Neurotrack's personalized health coaching platform.
Health Education	Health Education	Participants randomized to the control arm will receive digital health education materials that mirror the content in the app.

Primary Outcome Measures

Name	Time	Method
Composite dementia risk	Baseline to 24 months	Change in dementia risk as determined by Australian National University Alzheimer's Disease Risk Index (ANU-ADRI). Scores range from -13 to 64, with higher scores representing a higher risk for dementia.

Secondary Outcome Measures

Name	Time	Method
Rate of cognitive decline	Baseline to 24 months	Change in rate of cognitive decline as determined by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Scores range from 40-160, with higher scores representing better cognitive function

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States