Search / 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

Launched by HAII CORP.LTD · Sep 25, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

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.

Gender

ALL

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).

About Haii Corp.Ltd

haii corp. ltd. is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on enhancing patient outcomes, the company specializes in designing and conducting clinical trials across various therapeutic areas. Leveraging cutting-edge technology and a commitment to ethical standards, haii corp. ltd. collaborates with healthcare professionals, regulatory bodies, and industry partners to ensure the successful execution of studies that meet rigorous scientific and regulatory requirements. Their expertise in trial management and patient engagement positions them as a trusted leader in the clinical research landscape.

Locations

Chuncheon, Kangwon, Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0