RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07174869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is part of BU-ADRC cohort.
  2. * 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.
  3. * Participant is between 50 and 90 years old, included.
  4. * Participant is able to use a smartphone.
  5. * Participant has sufficient knowledge of the English language.
  6. * Participant is able to and has an intention to follow the study procedures.
  7. * Informed Consent as documented by signature.
  1. * Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
  2. * Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
  3. * Participant has a history of stroke or seizures within the last 24 months.
  4. * Participant has a Geriatric Depression Scale (GDS) score ≥8.
  5. * Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
  6. * Known or suspected non-compliance.

Contacts and Locations

Study Locations (Sites)

Boston University School of Medicine
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Indivi AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-09
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment (MCI)
  • Mild Alzheimer Disease