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 | Recruiting

• 1 other identifier: G00020
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 3

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.

Conditions

Dementia; Major Neurocognitive Disorder

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC)

  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.

  up to 8 months

Secondary Outcomes (2)

• Sensitivity

  up to 8 months

• Specificity

  up to 8 months

Study Arms (1)

ALZGUARD Intervention Group

EXPERIMENTAL

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

Device: ALZGUARD

Interventions

ALZGUARD DEVICE

A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.

ALZGUARD Intervention Group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• HAII corp.ltd: lead

Study Sites (3)

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

RECRUITING

Ewha Womans University Mokdong Medical Center

Seoul, South Korea

RECRUITING

Yongin Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rachel Lee

CONTACT

+82 10-7390-5023; rachel.lee@haii.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In this study, there will be two data analysts involved. Analyst 1 will be responsible for analyzing the results generated by the ALZGUARD application, which are based on the ALZGUARD AI model. This analyst will assess whether each subject has dementia and the likelihood or probability of the diagnosis. Analyst 1 will be blinded to any clinical assessments or dianoses made by the neurologists.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, interventional clinical trial designed to evlauate the efficacy and safety of ALZGAURD, a smartphone-based digital therapeutic, in detecting dementia. Study type: interentional (clinical trial) Masking: Single-blind (Outcomes assessor) Intervention description: The ALZGUARD application will be used by participants to assess cognitive function. Results will be compared to clinical diagnoses made by neurologists. Primary Outcome: the accuracy of the ALZGUARD diagnosis, measured by Area Under the Curve.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 26, 2024
• Study Start: September 12, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

KR (3)