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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
Sponsor: HAII corp.ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2024-09-12
Completion Date
2025-04-30
Last Updated
2024-09-26
Healthy Volunteers
No
Conditions
Interventions
ALZGUARD
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