Cognitive WellnessMEVANCT07595250
MEVA Cognitive Wellness Platform Study for Adults
An observational study of Cognitive Wellness and Healthy Aging, run by Mentage LLC.
Trial summary
The goal of this observational study is to evaluate the reliability, usability, and feasibility of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Wellness, Healthy Aging, Age-Related Cognitive Change
- What is being tested?
- MEVA Cognitive Wellness Platform
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling adults aged 55 to 75 years who are generally healthy or have stable chronic conditions and are interested in cognitive wellness research. Participants are recruited through community-based outreach, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity.
Who may be able to join
- Adults aged 55 to 75 years
- Community-dwelling (living independently in the community)
- English fluency sufficient for informed consent, task instructions, and questionnaires
- Able to provide informed consent using teach-back method
- Able to use a computer or tablet for simple tap or drag interactions
- Functional vision sufficient for on-screen tasks with usual corrective lenses
Show all 11Show fewer
- Functional hearing sufficient for spoken instructions with or without hearing aids
- Interest in cognitive wellness and personal well-being
- Available for baseline visit and possible retest visit approximately 14 days later
- Transportation to study site or ability to participate remotely if permitted by protocol
- Assistive devices and accommodations are permitted
Who cannot join
- Severe visual impairment preventing completion of digital tasks
- Severe motor impairment preventing interaction with tablet or web application
- Known diagnosis of moderate or severe dementia, or inability to comprehend consent and task instructions
- Current participation in another cognitive training or technology intervention study likely to confound outcomes
- Recent hospitalization, emergency room visit, or acute exacerbation of a medical or psychiatric condition within the past 30 days that would impede study participation
- Current substance use disorder likely to interfere with study adherence or completion
- Recent intensive use of a similar structured cognitive wellness or brain training application
About this study
Official title: Phase 1 Validation Study of the MEVA Cognitive Wellness Platform
The goal of this observational study is to evaluate the reliability, usability, and feasibility of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75.
The main questions it aims to answer are:
Read more
How consistent is the MEVA Global Cognitive Index when participants complete the MEVA activities again approximately 14 days later? How usable and acceptable is the MEVA platform for older adults in community settings? What completion rates, data quality patterns, and participant feedback are observed during use of the platform?
Participants will:
Complete a baseline study visit lasting approximately 45 to 60 minutes Complete a 7-activity digital cognitive wellness battery Answer questionnaires about usability, technology acceptance, and wellness experience Complete the Saint Louis University Mental Status (SLUMS) examination as an exploratory comparison measure If selected for the retest group, return approximately 14 days later to complete the MEVA activities again
MEVA is being evaluated as a cognitive wellness platform. It is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition.
Read the detailed description
This is a prospective, single-center, observational psychometric validation study of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75.
Platform Overview MEVA is a digital cognitive wellness platform developed by Mentage LLC to support cognitive engagement and healthy aging. MEVA uses real-world, Montessori-informed digital activities designed for older adult usability, autonomy, and engagement. The platform is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition, and is not used for clinical decision-making.
Study Purpose The primary objective is to evaluate test-retest reliability of the MEVA Global Cognitive Index over approximately 14 days. Secondary objectives include assessing usability, feasibility, task completion rates, internal consistency, participant experience, and exploratory convergent validity with an established cognitive measure.
Study Design All enrolled participants complete a baseline visit including informed consent, eligibility confirmation, demographic and health questionnaires, the PHQ-4 distress screening, the MEVA 7-activity digital cognitive wellness battery, the Saint Louis University Mental Status (SLUMS) examination, System Usability Scale, Technology Acceptance Model questionnaire, and brief qualitative feedback. The baseline visit lasts approximately 45 to 60 minutes.
The MEVA battery includes seven digital activities across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function. Performance across activities is combined into domain composite scores, which are then combined into the MEVA Global Cognitive Index, a composite wellness metric.
A randomly selected subset of participants (approximately 48 to 50) will complete a second visit approximately 14 days after baseline (allowed window: 11 to 17 days). At the retest visit, participants repeat the MEVA battery and complete a brief satisfaction questionnaire. The retest visit lasts approximately 30 to 35 minutes.
Recruitment and Health Equity Considerations Recruitment is community-based, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity. The study includes exploratory descriptive analyses examining MEVA performance, usability, and participant experience across age, education, technology experience, and self-reported health status to inform future culturally responsive wellness platform development.
Outcomes The primary outcome is test-retest reliability of the MEVA Global Cognitive Index, measured by intraclass correlation coefficient (ICC). Success is defined as ICC point estimate ≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
Secondary and exploratory outcomes include domain-level reliability, activity-level reliability, internal consistency (Cronbach's alpha, McDonald's omega), System Usability Scale score, Technology Acceptance Model scores, task completion rates, validity flag frequency, practice effects between visits, exploratory correlation with SLUMS total score, and exploratory age-stratified wellness score distributions.
Provisional Wellness Feedback Participants may receive provisional wellness feedback during or after MEVA completion. Any feedback is for research and wellness purposes only. It is not a medical assessment, diagnosis, screening result, treatment recommendation, or clinical interpretation.
Study Rationale This study provides foundational psychometric evidence to support MEVA's use as a wellness engagement tool in community and primary care settings. Findings will inform future validation studies in larger, more diverse populations and explore MEVA's potential role in health equity research and community-based cognitive wellness initiatives.
- Conditions
- Cognitive Wellness, Healthy Aging, Age-Related Cognitive Change, Aging, Cognitive Change, Health Behavior
- Being tested
- MEVA Cognitive Wellness Platform
- Keywords
- Cognitive wellness, Healthy aging, Health equity, Test-retest reliability, Community-dwelling older adults, Primary care, Digital wellness, Older adult engagement, Psychometrics, Usability, Community health, Wellness tracking, Cognitive engagement, Adult development, General wellness, Montessori-informed activities, Technology acceptance, Exploratory convergent validity
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEVA Cognitive Wellness PlatformBehavioural
Also called MEVA Mentage Engagement and Vitality Assessment, Montessori Engagement and Vitality Assessment
Participants complete an activity digital cognitive wellness battery designed to evaluate reliability, usability, feasibility, participant experience, and data quality. MEVA is being evaluated as a general wellness platform and is not used to diagnose, treat, prevent, screen for, or monitor any disease or medical condition.
| Study group | Role | What they receive |
|---|---|---|
| MEVA Study Cohort | Community-dwelling adults aged 55 to 75 who complete the MEVA digital cognitive wellness battery at baseline. A subset of participants will complete the MEVA battery again approximately 14 days later to assess test-retest reliability. Receives: Behavioral: MEVA Cognitive Wellness Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability of the MEVA Global Cognitive Index
Intraclass correlation coefficient (ICC) for the MEVA Global Cognitive Index between baseline and retest visits. The Global Cognitive Index is a composite wellness metric derived from performance across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function.
Reliability will be estimated using ICC(3,1), two-way mixed effects model, absolute agreement, single measurement. Success criterion: ICC point estimate
≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
Measured: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)
Secondary outcomes (6)
Task completion rate
Proportion of MEVA digital activities completed without technical errors or participant withdrawal from the activity.
Measured: Baseline and 14-day retest (11-17 day window)
Exploratory convergent validity with SLUMS
Pearson correlation between MEVA Global Cognitive Index at baseline and Saint Louis University Mental Status (SLUMS) examination total score.
Measured: Baseline (Visit 1)
Exploratory age-stratified score distributions
Descriptive statistics (mean, standard deviation, percentiles) for MEVA Global Cognitive Index and domain composite scores, stratified by age groups within the 55-75 year study population.
Measured: Baseline (Visit 1)
Test-Retest Reliability of Individual MEVA Digital Activity Scores
Test-retest reliability of individual MEVA digital activity scores, measured by the intraclass correlation coefficient (ICC). ICC is a reliability statistic (not a correlation between different measures) ranging from 0 to 1, with higher values indicating greater consistency when the same measure is administered twice. ICC will be calculated using ICC(3,1), a two-way mixed effects model with absolute agreement for single measurements. Each MEVA digital activity generates a numerical performance score at baseline and retest; ICC quantifies the stability of these scores over approximately 14 days.
Measured: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)
Test-Retest Reliability of MEVA Domain Composite Scores
Test-retest reliability of MEVA domain composite scores, measured by intraclass correlation coefficient (ICC). ICC is a reliability statistic (not a correlation between different measures) ranging from 0 to 1, with higher values indicating greater consistency when the same measure is administered twice. ICC will be calculated using ICC(3,1), a two-way mixed effects model with absolute agreement for single measurements. MEVA generates domain composite scores for four cognitive wellness domains (visuospatial ability, processing speed, language, and executive function) at baseline and retest; ICC quantifies the stability of these domain scores over approximately 14 days.
Measured: Baseline and 14-day retest (11-17 day window)
Technology Acceptance Model Questionnaire Subscale Scores
Technology Acceptance Model (TAM) questionnaire scores for perceived usefulness and perceived ease of use of the MEVA platform. Items are rated on a 1 to 7 Likert scale. Subscale scores are calculated as mean item scores ranging from 1 to 7, with higher scores indicating greater perceived usefulness or ease of use.
Measured: Baseline (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive WellnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mentage LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dwight Bellingham, MD, Principal investigator, Bellingham Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595250
- Sponsor's protocol ID
- MEVA-P1-2026
- Other IDs
- 26-08-039-2503
- Acronym
- MEVA
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to small sample size (target n=40 complete test-retest pairs), participant privacy considerations, and proprietary platform development. Aggregate results will be reported in scientific publications and regulatory summaries.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Validation Study of the MEVA Cognitive Wellness Platform
- ClinicalTrials.gov ID
- NCT07595250
- Acronym / sponsor ID
- MEVA / MEVA-P1-2026
- Conditions
- Cognitive Wellness, Healthy Aging, Age-Related Cognitive Change, Aging, Cognitive Change, Health Behavior
- Keywords
- Cognitive wellness, Healthy aging, Health equity, Test-retest reliability, Community-dwelling older adults, Primary care, Digital wellness, Older adult engagement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mentage LLCIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2026 (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 goal of this observational study is to evaluate the reliability, usability, and feasibility of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75.
The main questions it aims to answer are:
How consistent is the MEVA Global Cognitive Index when participants complete the MEVA activities again approximately 14 days later? How usable and acceptable is the MEVA platform for older adults in community settings? What completion rates, data quality patterns, and participant feedback are observed during use of the platform?
Participants will:
Complete a baseline study visit lasting approximately 45 to 60 minutes Complete a 7-activity digital cognitive wellness battery Answer questionnaires about usability, technology acceptance, and wellness experience Complete the Saint Louis University Mental Status (SLUMS) examination as an exploratory comparison measure If selected for the retest group, return approximately 14 days later to complete the MEVA activities again
MEVA is being evaluated as a cognitive wellness platform. It is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition.
Detailed description
This is a prospective, single-center, observational psychometric validation study of the MEVA Cognitive Wellness Platform in community-dwelling adults aged 55 to 75.
Platform Overview MEVA is a digital cognitive wellness platform developed by Mentage LLC to support cognitive engagement and healthy aging. MEVA uses real-world, Montessori-informed digital activities designed for older adult usability, autonomy, and engagement. The platform is not intended to diagnose, treat, prevent, screen for, or monitor any disease or medical condition, and is not used for clinical decision-making.
Study Purpose The primary objective is to evaluate test-retest reliability of the MEVA Global Cognitive Index over approximately 14 days. Secondary objectives include assessing usability, feasibility, task completion rates, internal consistency, participant experience, and exploratory convergent validity with an established cognitive measure.
Study Design All enrolled participants complete a baseline visit including informed consent, eligibility confirmation, demographic and health questionnaires, the PHQ-4 distress screening, the MEVA 7-activity digital cognitive wellness battery, the Saint Louis University Mental Status (SLUMS) examination, System Usability Scale, Technology Acceptance Model questionnaire, and brief qualitative feedback. The baseline visit lasts approximately 45 to 60 minutes.
The MEVA battery includes seven digital activities across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function. Performance across activities is combined into domain composite scores, which are then combined into the MEVA Global Cognitive Index, a composite wellness metric.
A randomly selected subset of participants (approximately 48 to 50) will complete a second visit approximately 14 days after baseline (allowed window: 11 to 17 days). At the retest visit, participants repeat the MEVA battery and complete a brief satisfaction questionnaire. The retest visit lasts approximately 30 to 35 minutes.
Recruitment and Health Equity Considerations Recruitment is community-based, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity. The study includes exploratory descriptive analyses examining MEVA performance, usability, and participant experience across age, education, technology experience, and self-reported health status to inform future culturally responsive wellness platform development.
Outcomes The primary outcome is test-retest reliability of the MEVA Global Cognitive Index, measured by intraclass correlation coefficient (ICC). Success is defined as ICC point estimate ≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
Secondary and exploratory outcomes include domain-level reliability, activity-level reliability, internal consistency (Cronbach's alpha, McDonald's omega), System Usability Scale score, Technology Acceptance Model scores, task completion rates, validity flag frequency, practice effects between visits, exploratory correlation with SLUMS total score, and exploratory age-stratified wellness score distributions.
Provisional Wellness Feedback Participants may receive provisional wellness feedback during or after MEVA completion. Any feedback is for research and wellness purposes only. It is not a medical assessment, diagnosis, screening result, treatment recommendation, or clinical interpretation.
Study Rationale This study provides foundational psychometric evidence to support MEVA's use as a wellness engagement tool in community and primary care settings. Findings will inform future validation studies in larger, more diverse populations and explore MEVA's potential role in health equity research and community-based cognitive wellness initiatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEVA Study Cohort | – | Behavioral: MEVA Cognitive Wellness PlatformCommunity-dwelling adults aged 55 to 75 who complete the MEVA digital cognitive wellness battery at baseline. A subset of participants will complete the MEVA battery again approximately 14 days later to assess test-retest reliability. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling adults aged 55 to 75 years who are generally healthy or have stable chronic conditions and are interested in cognitive wellness research. Participants are recruited through community-based outreach, including senior centers, libraries, faith-based organizations, wellness programs, and word of mouth. Recruitment is designed to support demographic and socioeconomic diversity.
Key inclusion criteria (11 listed)
- Adults aged 55 to 75 years
- Community-dwelling (living independently in the community)
- English fluency sufficient for informed consent, task instructions, and questionnaires
- Able to provide informed consent using teach-back method
- Able to use a computer or tablet for simple tap or drag interactions
Key exclusion criteria (7 listed)
- Severe visual impairment preventing completion of digital tasks
- Severe motor impairment preventing interaction with tablet or web application
- Known diagnosis of moderate or severe dementia, or inability to comprehend consent and task instructions
- Current participation in another cognitive training or technology intervention study likely to confound outcomes
- Recent hospitalization, emergency room visit, or acute exacerbation of a medical or psychiatric condition within the past 30 days that would impede study participation
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 |
|---|---|---|
| MEVA Cognitive Wellness PlatformAlso: MEVA Mentage Engagement and Vitality Assessment, Montessori Engagement and Vitality AssessmentParticipants complete an activity digital cognitive wellness battery designed to evaluate reliability, usability, feasibility, participant experience, and data quality. MEVA is being evaluated as a general wellness platform and is not used to diagnose, treat, prevent, screen for, or monitor any disease or medical condition. | Behavioural | MEVA Study Cohort |
Primary outcome
Test-retest reliability of the MEVA Global Cognitive Index
Time frame: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)
Intraclass correlation coefficient (ICC) for the MEVA Global Cognitive Index between baseline and retest visits. The Global Cognitive Index is a composite wellness metric derived from performance across four cognitive wellness domains: visuospatial ability, processing speed, language, and executive function. Reliability will be estimated using ICC(3,1), two-way mixed effects model, absolute agreement, single measurement. Success criterion: ICC point estimate ≥ 0.75 with lower 95% confidence interval bound ≥ 0.60.
6 secondary outcomes
Task completion rate
Time frame: Baseline and 14-day retest (11-17 day window)
Exploratory convergent validity with SLUMS
Time frame: Baseline (Visit 1)
Exploratory age-stratified score distributions
Time frame: Baseline (Visit 1)
Test-Retest Reliability of Individual MEVA Digital Activity Scores
Time frame: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)
Test-Retest Reliability of MEVA Domain Composite Scores
Time frame: Baseline and 14-day retest (11-17 day window)
Technology Acceptance Model Questionnaire Subscale Scores
Time frame: Baseline (Visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to small sample size (target n=40 complete test-retest pairs), participant privacy considerations, and proprietary platform development. Aggregate results will be reported in scientific publications and regulatory summaries.
Related trials for Cognitive Wellness
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Active, not recruiting
Cognitive Behavioral and Faith Fellowship to Improve Thy Health
Depression
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
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.
Dwight Bellingham, MD principal investigator
Bellingham Family Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Wellness and Healthy Aging, run by Mentage LLC.
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 11 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Test-retest reliability of the MEVA Global Cognitive Index (time frame: Baseline (Visit 1) and retest approximately 14 days later (Visit 2, allowed window 11-17 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.