Testing the Safety and Accuracy of ALZGUARD, a Smartphone Tool for Diagnosing Dementia in Adults Aged 55 to 85

What this Trial Is About

Researchers are evaluating the effectiveness and safety of ALZGUARD, a smartphone-based digital therapeutic application designed to assist in diagnosing major neurocognitive disorders such as dementia. This study compares ALZGUARDs diagnostic accuracy with traditional evaluations conducted by medical doctors. The study involves participants aged 55 to 85 years and aims to measure how well ALZGUARD identifies dementia compared to standard methods. All participants will use the ALZGUARD application to assess cognitive function. The study follows a single-arm design where everyone uses this digital tool. The primary measure of success is the Area Under the Curve AUC over up to 8 months, which evaluates the diagnostic performance of ALZGUARD. Secondary measures include sensitivity and specificity of the diagnosis. Participants will be monitored during the study period, which lasts up to eight months, to collect diagnostic data from the ALZGUARD application. Researchers will assess the applications ability to detect dementia accurately. Safety and diagnostic effectiveness are tracked throughout, with no masking or placebo groups involved. This multi-center study is overseen by HAII corp.ltd to ensure thorough evaluation and participant safety.

Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders