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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALZGUARD.
- Who it may be relevant to
- Registry conditions: Dementia, Major Neurocognitive Disorder. Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device ALZGUARD
A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.
Primary outcome measures
- Area Under the Curve (AUC) [Time frame: up to 8 months]
Secondary outcome measures (2)
- Sensitivity [Time frame: up to 8 months]
- Specificity [Time frame: up to 8 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
South Korea · 3 centers
- Kangwon National University Hospital — Chuncheon
- Ewha Womans University Mokdong Medical Center — Seoul
- Yongin Severance Hospital — Seoul
Identifiers
NCT: NCT06615167 · G00020