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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorHAII corp.ltd

About this trial

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

Qualifiers

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.

Disqualifiers

Participants with no literacy or illiteracy.

Participants with an intellectual disability.

Participants with presenting active psychiatric symptoms.

Participants who have difficulty ALZGUARD application

Trial design

Treatments tested in this trial

  • ALZGUARD

Treatment groups

122 Participants
are divided into 1 treatment group

Locations

3
Kangwon National University Hospital ChuncheonGangwon-do, South Korea
Ewha Womans University Mokdong Medical Center Seoul South Korea
Yongin Severance Hospital Seoul South Korea

Sponsors and collaborators

HAII corp.ltd

Lead sponsor