Evaluating a smartphone app for diagnosing dementia
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
This study is testing a smartphone app called ALZGUARD to see if it can accurately diagnose dementia in people aged 55 to 85 compared to regular doctor evaluations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | HAII corp.ltd Industry-sponsored |
| Locations | 3 sites (Chuncheon, Gangwon-do and 2 other locations) |
| Trial ID | NCT06615167 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of ALZGUARD, a digital therapeutic tool designed for diagnosing major neurocognitive disorders, specifically dementia. Participants aged 55 to 85 will be enrolled across multiple sites, where the diagnostic accuracy of ALZGUARD will be compared to traditional evaluations conducted by medical professionals. The primary endpoint will be the Area Under the Curve (AUC), which will measure how effectively ALZGUARD identifies dementia compared to standard diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 to 85 who can understand and agree to participate in the trial.
Not a fit: Patients who are illiterate, have intellectual disabilities, or are unable to use a smartphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could provide a more accessible and accurate means of diagnosing dementia, potentially leading to earlier intervention.
How similar studies have performed: Other studies have shown promise in using digital tools for diagnostic purposes, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Chuncheon, Gangwon-do and 2 other locations
- Kangwon National University Hospital — Chuncheon, Gangwon-do, South Korea (Recruiting)
- Ewha Womans University Mokdong Medical Center — Seoul, South Korea (Recruiting)
- Yongin Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Rachel Lee
- Email: rachel.lee@haii.io
- Phone: +82 10-7390-5023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.