A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Mild Alzheimer Disease. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
Overview
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.
Primary outcome measures
- Number of test iterations until stable difficulty level is reached [Time frame: During the 6-week study period.]
- Distribution of participants across assessment levels at steady-state difficulty [Time frame: During the 6-week study period]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Boston University School of Medicine — Boston
Identifiers
NCT: NCT07174869 · H-45373