A multicenter, patient-control exploratory clinical trial is conducted to assess the clinical efficacy and safety of a virtual reality-based cognitive assessment software (VARABOM-Diagnosis) designed to assist in the screening diagnosis of mild cognitive impairment (MCI) by evaluating cognitive functions in patients with MCI.

Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 84 人开始时间: 待定最近更新: 2024年3月4日

适应症

试验速览

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•A. Mild Cognitive Impairment (MCI) Group (individuals meeting all of the following criteria):
•1) Participants aged 60 or older who have consented to research participation
•2) Individuals who have a sufficient understanding of and provide consent for the research purpose and process
•3) Those who subjectively report cognitive decline or are acknowledged by family members for cognitive impairment
•4) Individuals with overall preserved cognitive function and, as judged by a physician, exhibit no problems in daily life
•5) Participants with a Clinical Dementia Rating (CDR) score of 0.5
•6) Individuals with a CDR Sum of Boxes (CDR-SB) score of 4 or lower, indicating no dementia-related functional issues in daily life
•B. Healthy Control Group (individuals meeting all of the following criteria):
•1) Participants aged 60 or older who have consented to research participation
•2) Individuals who have a sufficient understanding of and provide consent for the research purpose and process
•3) Participants with a Clinical Dementia Rating (CDR) score of 0.

•(Individuals meeting any of the following criteria will be excluded):
•1) Presence of clinically significant internal medicine or neurological conditions, such as severe medical conditions or acute viral brain diseases, which could significantly impact mental health
•2) Presence of mood disorders, schizophrenia spectrum disorders, substance use disorders, or alcohol use disorders
•3) Difficulty wearing virtual reality (VR) equipment
•4) Individuals with visual impairments - those unable to read normal text even with glasses for visual reasons
•5) Individuals with hearing impairments - those who, even with hearing aids, find it difficult to understand conversation for auditory reasons
•6) Those deemed by the clinician to have difficulty communicating effectively with the researcher, without the possibility of assistance from a guardian
•7) Those deemed by the clinician to be unable to read the consent form, without the possibility of assistance from a guardian
•8) Other individuals deemed by the investigator to be ineligible for participation in this clinical trial
•9) Individuals who have taken cognitive enhancers (donepezil, rivastigmine, galantamine, memantine) within the last 6 months.

发起方

Yonsei University Health System, Gangnam Severance Hospital