Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Major Neurocognitive Disorder
Lead sponsor: HAII corp.ltd
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 122
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Area Under the Curve (AUC)
timeFrame: up to 8 months
Secondary outcomes:
measure: Sensitivity
timeFrame: up to 8 months
measure: Specificity
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Kangwon
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Medical Center
city: Seoul
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
References: