Reducing Dementia Risk With Digital Health Coaching (DC-MARVEL)

August 30, 2021 updated by: Neurotrack Technologies, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • University of Arkansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: Health Education
Participants randomized to the control arm will receive digital health education materials that mirror the content in the app.
Other: Health Education
Health education materials delivered electronically

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurotrack Technologies, Inc.

Collaborators

National Institute on Aging (NIA)
University of Arkansas

Investigators

  • Principal Investigator: Jordan Glenn, PhD, Neurotrack Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2021

Primary Completion (ANTICIPATED)

January 30, 2024

Study Completion (ANTICIPATED)

January 30, 2024

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R44AG063672-01 (NIH)
  • R44AG063672 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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