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

NCT07174869 | Recruiting

• 1 other identifier: H-45373
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Mild Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Number of test iterations until stable difficulty level is reached

  Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.

  During the 6-week study period.

• Distribution of participants across assessment levels at steady-state difficulty

  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.

  During the 6-week study period

Study Arms (2)

PwMCI/AD

Persons with Mild Cognitive Impairment or mild Alzheimer's Disease

HC

Healthy Controls

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Boston University Alzheimer's Disease Research Center (BU ADRC)

You may qualify if:

• Participant is part of BU-ADRC cohort.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivi AG: lead

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)