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

NCT ID: NCT07174869

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PwMCI/AD

Persons with Mild Cognitive Impairment or mild Alzheimer's Disease

No interventions assigned to this group

HC

Healthy Controls

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indivi AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Burk, Alexa

Role: primary

lexiburk@bu.edu

617-358-1959

Other Identifiers

H-45373

Identifier Type: -

Identifier Source: org_study_id