NCT07174869 · Indivi AG
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
(ADAPT-MCI-01)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2025 · Source of record for eligibility and locations