Reducing Dementia Risk With Digital Health Coaching

Alzheimer Disease Clinical Trial

— DC-MARVEL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04559789
• Other study ID #: 1R44AG063672-01
• Secondary ID: R44AG063672
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: August 2021
• Source: Neurotrack Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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.

Other:
• Health Education
Health education materials delivered electronically

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Neurotrack Technologies, Inc.	National Institute on Aging (NIA), University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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