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
| NCT ID | NCT06615167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HAII corp.ltd |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2024-09-12 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 122 participants in total. It began in 2024-09-12 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06615167 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06615167 currently recruiting?
Yes, NCT06615167 is actively recruiting participants. Contact the research team at rachel.lee@haii.io for enrollment information.
Where is the NCT06615167 trial being conducted?
This trial is being conducted at Chuncheon, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06615167 clinical trial?
NCT06615167 is sponsored by HAII corp.ltd. The trial plans to enroll 122 participants.