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
NCT06615167 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2024-09-26
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.
Conditions
- Dementia
- Major Neurocognitive Disorder
Interventions
- DEVICE
-
ALZGUARD
A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.
Sponsors & Collaborators
-
HAII corp.ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 55 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-12
- Primary Completion
- 2025-04-30
- Completion
- 2025-04-30
Countries
- South Korea
Study Locations
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