A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorIndivi AG
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Boston University Alzheimer's Disease Research Center (BU ADRC)
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
55 Participants
are grouped into 2 trial groupsGroup A: PwMCI/AD
Group B: HC
Trial outcomes
Primary outcomes
1
Number of test iterations until stable difficulty level is reached
Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.
Time frame
During the 6-week study period.2
Distribution of participants across assessment levels at steady-state difficulty
Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.
Time frame
During the 6-week study period Source ClinicalTrials.gov