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

Neurotrack Technologies

Status: Unknown

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline; Dementia

Treatments: Behavioral: MindMate + Health Coaching; Other: Health Education

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04559789

1R44AG063672-01

R44AG063672 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Digital Lifestyle Intervention

Experimental group

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.

Treatment:

Behavioral: MindMate + Health Coaching

Health Education

Active Comparator group

Description:

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

Treatment:

Other: Health Education