Alzheimer DiseaseDC-MARVELNCT04559789
Reducing Dementia Risk With Digital Health Coaching
A study testing MindMate + Health Coaching and Health Education in people with Alzheimer Disease and Dementia, run by Neurotrack Technologies, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- What is being tested?
- MindMate + Health Coaching and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72701
About this study
Official title: Digital Cognitive Multidomain Alzheimer's Risk Velocity Study (DC-MARVEL)
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.
Read the 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.
- Being tested
- MindMate + Health Coaching, Health Education
- Keywords
- Dementia prevention, Risk reduction, Multi-domain lifestyle intervention, Behavior change
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMate + Health CoachingBehavioural
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.
Health EducationOther
Health education materials delivered electronically
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 months
Secondary outcomes (1)
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
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start4 Jan 2021
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated to either the intervention or control group at the beginning of the study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotrack Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Jordan Glenn, PhD, Principal investigator, Neurotrack Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559789
- Sponsor's protocol ID
- 1R44AG063672-01
- Other IDs
- R44AG063672
- Acronym
- DC-MARVEL
- Status last verified
- Aug 2021
- First submitted
- 11 Sep 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39038282Campitelli 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.
PubMed 36705951Gray 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.
PubMed 35119374
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Multidomain Alzheimer's Risk Velocity Study (DC-MARVEL)
- ClinicalTrials.gov ID
- NCT04559789
- Acronym / sponsor ID
- DC-MARVEL / 1R44AG063672-01
- Keywords
- Dementia prevention, Risk reduction, Multi-domain lifestyle intervention, Behavior change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Neurotrack Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Arkansas
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to either the intervention or control group at the beginning of the study
| Arm | Type | Receives |
|---|---|---|
| Digital Lifestyle Intervention | Experimental | Behavioral: MindMate + Health CoachingParticipants 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. |
| Health Education | Active comparator | Other: Health EducationParticipants randomized to the control arm will receive digital health education materials that mirror the content in the app. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindMate + Health CoachingThe 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. | Behavioural | Digital Lifestyle Intervention |
| Health EducationHealth education materials delivered electronically | Other | Health Education |
Primary outcome
Composite dementia risk
Time frame: Baseline to 24 months
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.
1 secondary outcome
Rate of cognitive decline
Time frame: Baseline to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 39038282Myers 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.
- Derived from this study: PubMed 36705951Campitelli 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.
- Derived from this study: PubMed 35119374Gray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Glenn, PhD principal investigator
Neurotrack Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindMate + Health Coaching and Health Education in people with Alzheimer Disease and Dementia, run by Neurotrack Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite dementia risk (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559789, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.