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A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population | Clinical Trials | Clareo Health

RECRUITING

A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population

A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls

NCT07174869•Indivi AG

View on ClinicalTrials.gov

Summary

The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user. The main questions it aims to answer are: * Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC? * Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC? Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups. Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant is part of BU-ADRC cohort.
•Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.
•Participant is between 50 and 90 years old, included.
•Participant is able to use a smartphone.
•Participant has sufficient knowledge of the English language.
•Participant is able to and has an intention to follow the study procedures.
•Informed Consent as documented by signature.

Exclusion Criteria

•Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
•Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
•Participant has a history of stroke or seizures within the last 24 months.
•Participant has a Geriatric Depression Scale (GDS) score ≥8.
•Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
•Known or suspected non-compliance.

Locations (1)

Boston University School of Medicine

Boston, Massachusetts, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

September 16, 2025

Enrollment

ESTIMATED participants

Conditions

Mild Cognitive Impairment (MCI)Mild Alzheimer Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population

Inclusion Criteria

Exclusion Criteria

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