A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performanc… (NCT07174869) | Clinical Trial Compass
CompletedNot Applicable
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
United States32 participantsStarted 2025-09-19
Plain-language 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.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of test iterations until stable difficulty level is reached
Timeframe: During the 6-week study period.
2
Distribution of participants across assessment levels at steady-state difficulty