MEVA Cognitive Wellness Platform Study for Adults

Mentage LLC

Status: Not yet enrolling

Conditions: Aging; Age-Related Cognitive Change; Cognitive Change; Health Behavior; Cognitive Wellness; Primary Care; Healthy Aging

Treatments: Behavioral: MEVA Cognitive Wellness Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT07595250

MEVA-P1-2026

26-08-039-2503 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• 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

Exclusion criteria

• 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

Trial design

100 participants in 1 patient group

MEVA Study Cohort

Description:

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.

Treatment:

Behavioral: MEVA Cognitive Wellness Platform