Actively Recruiting

Phase Not Applicable
Age: 55Years - 85Years
All Genders
NCT06615167

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

Led by HAII corp.ltd · Updated on 2024-09-26

122

Participants Needed

3

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Participants with no literacy or illiteracy.
  • Participants with an intellectual disability.
  • Participants with presenting active psychiatric symptoms.
  • Participants who have difficulty using the ALZGUARD application.
  • Participants who are unable to use a smartphone, unless they can use it with assistance.
  • Participants with a history of suicidal ideation or suicidal compulsion in the last 6 months.
  • Other conditions deemed inappropriate for study participation by the Principal Investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Actively Recruiting

2

Ewha Womans University Mokdong Medical Center

Seoul, South Korea

Actively Recruiting

3

Yongin Severance Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

R

Rachel Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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