Reducing Dementia Risk With Digital Health Coaching

Study Overview
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Brief Summary
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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
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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.

Official Title
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Digital Cognitive Multidomain Alzheimer's Risk Velocity Study (DC-MARVEL)

Conditions
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Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Decline

Intervention / Treatment
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* Behavioral: MindMate + Health Coaching
* Other: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly allocated to either the intervention or control group at the beginning of the study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Lifestyle Intervention<br>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. | Behavioral: MindMate + Health Coaching<br>* The MindMate app is a digital multi-domain lifestyle intervention designed to address modifiable risk factors for dementia. The app will be augmented with digital health coaching provided by Neurotrack.<br>|
| Active Comparator: Health Education<br>Participants randomized to the control arm will receive digital health education materials that mirror the content in the app. | Other: Health Education<br>* Health education materials delivered electronically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite dementia risk | 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. | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cognitive decline | 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 | Baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia prevention, Risk reduction, Multi-domain lifestyle intervention, Behavior change