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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-12

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dementia Major Neurocognitive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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ALZGUARD Intervention Group

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

Group Type EXPERIMENTAL

ALZGUARD

Intervention Type DEVICE

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

Interventions

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ALZGUARD

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No