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

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Alzheimer Disease Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Burk, Alexa

CONTACT

[email protected]

617-358-1959

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of test iterations until stable difficulty level is reached

Time frame: During the 6-week study period.

Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.
Distribution of participants across assessment levels at steady-state difficulty

Time frame: During the 6-week study period

Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.

Sponsors and collaborators

Lead sponsor

Indivi AG

Industry

Registry information

Official study title

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

Acronym: ADAPT-MCI-01

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 16, 2025
Registry last updated: Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed