Indivi app for monitoring thinking and memory in older adults
A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
This project will test whether the Indivi smartphone app, which automatically adjusts task difficulty, can monitor thinking and memory over six weeks in people with mild cognitive impairment or mild Alzheimer's and in healthy older adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Indivi AG Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07174869 on ClinicalTrials.gov |
What this trial studies
This observational study asks people with MCI or mild Alzheimer's and healthy older adults to use the Indivi mobile app for a six-week period. The app delivers cognitive activities that adapt in real time using a dynamic difficulty adjustment (DDA) algorithm aimed at finding a stable difficulty level for each user. Researchers will compare how quickly the DDA reaches stability and whether the stable difficulty levels differ between the clinical and healthy groups, and will examine whether task results can distinguish the two groups. Usability and functionality data will also be collected to determine whether participants can reliably use the app at home.
Who should consider this trial
Good fit: Ideal candidates are BU-ADRC cohort members aged 50–90 who are diagnosed with MCI or mild Alzheimer's or classified as healthy controls, can use a smartphone, have sufficient English, and can give informed consent.
Not a fit: People with other neurological conditions beyond their MCI/AD, recent stroke or seizures, significant psychiatric symptoms, high depression scores, severe cognitive impairment, or those unable to use a smartphone are unlikely to benefit.
Why it matters
Potential benefit: If successful, the app could provide an easy, at-home way to track cognitive changes and help detect decline earlier.
How similar studies have performed: Previous research on smartphone-based cognitive testing has shown promise for remote monitoring, but using a dynamic difficulty adjustment system specifically in MCI/mild AD is relatively novel and less well validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Boston University School of Medicine — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.