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
HAII corp.ltd
122 participants
Sep 12, 2024
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
Inclusion Criteria2
- 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.
Exclusion Criteria7
- Participants with no literacy or illiteracy.
- Participants with an intellectual disability.
- Participants with presenting active psychiatric symptoms.
- Participants who have difficulty ALZGUARD application
- Participants who are unable to use a smartphone, unless they can use it with assistant.
- Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.
- Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).
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Interventions
A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06615167