The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.
Participants must be between 55 and 85 years old (both men and women).
Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.
Participants with no literacy or illiteracy.
Participants with an intellectual disability.
Participants with presenting active psychiatric symptoms.
Participants who have difficulty ALZGUARD application
Single group
ALZGUARD
DeviceA digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.
Area Under the Curve (AUC)
The primary outcome will be the Area Under the Curve (AUC), which will assess the diagnostic accuracy of ALZGUARD by comparing its results with the clinical diagnosis made by neurologists. AUC will be calculated to determine the performance of ALZGUARD in detecting dementia.
Sensitivity
The one of the secondary outcome will measure the sensitivity of ALZGUARD in detecting dementia. Sensitivity refers to the proportion of true positive cases accurately identified by ALZGUARD, compared to clinical diagnosis made by neurologists. This measure will assess the ability of ALZGUARD to correctly identiry patients who have dementia.
Specificity
Specificity refers to the proportion of true negative cases accurately identified by ALZGUARD, compared to the clinical diagnosis made by neurologists. This outcome will assess the ability of ALZGUARD to correctly identify patient who do not have dementia.
Click on the lead sponsor to view all of their trials.
