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NCT Number: 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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Major Neurocognitive Disorder Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangwon National University Hospital, Chuncheon, Gangwon-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ALZGUARD

Device

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

Primary outcomes

  1. Area Under the Curve (AUC)

    Time frame: 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 outcomes

  1. Sensitivity

    Time frame: 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.

  2. Specificity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Lee

CONTACT

[email protected]

+82 10-7390-5023

Sponsors and collaborators

Lead sponsor

HAII corp.ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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