Reducing Dementia Risk With Digital Health Coaching

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2024-01-30

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.

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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.

Conditions

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Alzheimer Disease Dementia Mild Cognitive Impairment Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly allocated to either the intervention or control group at the beginning of the study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

All study investigators that collect or analyze data are blinded to the group assignment for all participants.

Study Groups

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Digital Lifestyle Intervention

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.

Group Type EXPERIMENTAL

MindMate + Health Coaching

Intervention Type BEHAVIORAL

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.

Health Education

Participants randomized to the control arm will receive digital health education materials that mirror the content in the app.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type OTHER

Health education materials delivered electronically

Interventions

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MindMate + Health Coaching

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.

Intervention Type BEHAVIORAL

Health Education

Health education materials delivered electronically

Intervention Type OTHER

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes