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

HAII

Status

Enrolling

Conditions

Major Neurocognitive Disorder

Dementia

Treatments

Device: ALZGUARD

Study type

Interventional

Funder types

Industry

Identifiers

NCT06615167

G00020

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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).