RecruitingNot ApplicableNCT06615167

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

A Single-blind (Data Analyst 1), Single-arm Design, Prospective, Multi-center 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 According to DSM-5


Sponsor

HAII corp.ltd

Enrollment

122 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ALZGUARD for people with dementia and major neurocognitive disorder. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 55 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEALZGUARD

A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.


Locations(3)

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Ewha Womans University Mokdong Medical Center

Seoul, South Korea

Yongin Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06615167


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