Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT07174869
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
Sponsor:
Indivi AG
Organization:
Study Overview
Official Title:
A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT-MCI-01
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: