A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population (ADAPT-MCI-01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment (MCI); Mild Alzheimer Disease

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston University School of Medicine
      • Contact: Burk, Alexa; Phone Number: 617-358-1959; Email: lexiburk@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HC; Healthy Controls
PwMCI/AD; Persons with Mild Cognitive Impairment or mild Alzheimer's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indivi AG

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: H-45373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No