Clinical trial NCT04559789: Reducing Dementia Risk With Digital Health Coaching
Official title: Digital Cognitive Multidomain Alzheimer's Risk Velocity Study (DC-MARVEL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Cognitive Decline
Keywords: Dementia prevention
Risk reduction
Multi-domain lifestyle intervention
Behavior change
Lead sponsor: Neurotrack Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: University of Arkansas
First posted: 2020-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly allocated to either the intervention or control group at the beginning of the study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Composite dementia risk
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Rate of cognitive decline
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: Neurotrack Technologies, Inc.
name: Jordan Glenn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.