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

Primary Purpose

Alzheimer Disease, Dementia, Mild Cognitive Impairment

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MindMate + Health Coaching
Health Education
Sponsored by
Neurotrack Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Dementia prevention, Risk reduction, Multi-domain lifestyle intervention, Behavior change

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Lifestyle Intervention

Health Education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2020
Last Updated
August 30, 2021
Sponsor
Neurotrack Technologies, Inc.
Collaborators
National Institute on Aging (NIA), University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04559789
Brief Title
Reducing Dementia Risk With Digital Health Coaching
Acronym
DC-MARVEL
Official Title
Digital Cognitive Multidomain Alzheimer's Risk Velocity Study (DC-MARVEL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurotrack Technologies, Inc.
Collaborators
National Institute on Aging (NIA), University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Decline
Keywords
Dementia prevention, Risk reduction, Multi-domain lifestyle intervention, Behavior change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly allocated to either the intervention or control group at the beginning of the study
Masking
InvestigatorOutcomes Assessor
Masking Description
All study investigators that collect or analyze data are blinded to the group assignment for all participants.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Participants randomized to the control arm will receive digital health education materials that mirror the content in the app.
Intervention Type
Behavioral
Intervention Name(s)
MindMate + Health Coaching
Intervention Description
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
Other
Intervention Name(s)
Health Education
Intervention Description
Health education materials delivered electronically
Primary Outcome Measure Information:
Title
Composite dementia risk
Description
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.
Time Frame
Baseline to 24 months
Secondary Outcome Measure Information:
Title
Rate of cognitive decline
Description
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
Time Frame
Baseline to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Glenn, PhD
Organizational Affiliation
Neurotrack Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35119374
Citation
Gray M, Madero EN, Gills JL, Paulson S, Jones MD, Campitelli A, Myers J, Bott NT, Glenn JM. Intervention for a Digital, Cognitive, Multi-Domain Alzheimer Risk Velocity Study: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Feb 4;11(2):e31841. doi: 10.2196/31841.
Results Reference
derived

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Reducing Dementia Risk With Digital Health Coaching

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