NCT04559789

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

3.1 years

First QC Date

September 11, 2020

Last Update Submit

August 30, 2021

Conditions

Alzheimer DiseaseDementiaMild Cognitive ImpairmentCognitive Decline

Keywords

Dementia preventionRisk reductionMulti-domain lifestyle interventionBehavior change

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of cognitive decline

    Baseline to 24 months

Study Arms (2)

Digital Lifestyle Intervention

EXPERIMENTAL

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

Health Education

ACTIVE COMPARATOR

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

Other: Health Education

Interventions

MindMate + Health CoachingBEHAVIORAL

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.

Digital Lifestyle Intervention
Health EducationOTHER

Health education materials delivered electronically

Health Education

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

Related Publications (3)

  • Myers JR, Bryk KN, Madero EN, McFarlane J, Campitelli A, Gills J, Jones M, Paulson S, Gray M, Glenn JM. Initial Perspectives From Rural-Residing Adults on a Digital Cognitive Health Coaching Intervention: Exploratory Qualitative Analysis. JMIR Form Res. 2024 Jul 22;8:e51400. doi: 10.2196/51400.

    PMID: 39038282DERIVED

  • Campitelli A, Paulson S, Gills JL, Jones MD, Madero EN, Myers J, Glenn JM, Gray M. A Novel Digital Digit-Symbol Substitution Test Measuring Processing Speed in Adults At Risk for Alzheimer Disease: Validation Study. JMIR Aging. 2023 Jan 27;6:e36663. doi: 10.2196/36663.

    PMID: 36705951DERIVED

  • 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.

    PMID: 35119374DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementiaCognitive DysfunctionRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersBehavior

Study Officials

  • Jordan Glenn, PhD

    Neurotrack Technologies, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All study investigators that collect or analyze data are blinded to the group assignment for all participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomly allocated to either the intervention or control group at the beginning of the study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 23, 2020

Study Start

January 4, 2021

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)