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

Not Applicable

Recruiting

• Conditions: Dementia; Major Neurocognitive Disorder
• Interventions: Device: ALZGUARD

• Registration Number: NCT06615167
• Lead Sponsor: HAII corp.ltd

Brief 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.

Detailed Description

The study will be conducted across multiple sites, enrolling participants aged 55 to 85 years olds.

The primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals. The primary endpoint for efficacy will be the Area Under the Curve(AUC), which will measure the diagnostic performance of the application. This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-12
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• 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 Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALZGUARD Intervention Group	ALZGUARD	All participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC)	up to 8 months	The primary outcome will be the Area Under the Curve (AUC), which will assess the diagnostic accuracy of ALZGUARD by comparing its results with the clinical diagnosis made by neurologists. AUC will be calculated to determine the performance of ALZGUARD in detecting dementia.

Secondary Outcome Measures

Name	Time	Method
Sensitivity	up to 8 months	The one of the secondary outcome will measure the sensitivity of ALZGUARD in detecting dementia. Sensitivity refers to the proportion of true positive cases accurately identified by ALZGUARD, compared to clinical diagnosis made by neurologists. This measure will assess the ability of ALZGUARD to correctly identiry patients who have dementia.
Specificity	up to 8 months	Specificity refers to the proportion of true negative cases accurately identified by ALZGUARD, compared to the clinical diagnosis made by neurologists. This outcome will assess the ability of ALZGUARD to correctly identify patient who do not have dementia.

Trial Locations

Locations (3)

Kangwon National University Hospital; 🇰🇷 Chuncheon, Kangwon, Korea, Republic of

Ewha Womans University Mokdong Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yongin Severance Hospital; 🇰🇷 Seoul, Korea, Republic of