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Red-color sensitivity test as an early screening tool and severity index for Alzheimer’s dementia : Magnetic Resonance Imaging (MRI) study

Status Approved

  • First Submitted Date

    2020/08/10

  • Registered Date

    2020/11/18

  • Last Updated Date

    2020/11/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005606
    Unique Protocol ID 1922-015-400
    Public/Brief Title Red-color sensitivity test as an early screening tool and severity index for Alzheimer’s dementia : Magnetic Resonance Imaging (MRI) study
    Scientific Title Red-color sensitivity test as an early screening tool and severity index for Alzheimer’s dementia : Magnetic Resonance Imaging (MRI) study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1922-015-400
    Approval Date 2020-03-02
    Institutional Review Board Name Chung-ang university hospital, institutional review board
    Institutional Review Board Address 102, Heukseok-ro, Dongjak-gu, Seoul
    Institutional Review Board Telephone 02-6299-2738
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Doug Hyun Han
    Title Professor
    Telephone +82-2-6299-3132
    Affiliation Chung-Ang Univerisity Hospital
    Address Heukseok-ro 102, Dongjak-gu, Seoul
    Contact Person for Public Queries
    Name Hee Jin Kim
    Title Resident
    Telephone +82-2-6299-1508
    Affiliation Chung-Ang Univerisity Hospital
    Address Heukseok-ro 102, Dongjak-gu, Seoul
    Contact Person for Updating Information
    Name Jae Hyun Ryou
    Title Resident
    Telephone +82-2-6299-1508
    Affiliation Chung-Ang Univerisity Hospital
    Address Heukseok-ro 102, Dongjak-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-08-12 Actual
    Target Number of Participant 100
    Primary Completion Date 2021-08-12 , Anticipated
    Study Completion Date 2021-09-10 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-08-12 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chung-Ang Univerisity Hospital
    Organization Type Medical Institute
    Project ID 1922-015-400
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chung-Ang Univerisity Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1) Background of research
    Alzheimer's disease-induced dementia (AD) involves various brain areas that govern sensory and cognitive functions, and displays various clinical patterns, making early diagnosis difficult and often missing the right time to intervene in treatment. In order to delay or prevent symptoms of dementia, it is essential to develop biomarkers to determine the early screening and severity of AD.
    Visual stimuli are detected through three types of cones in the eye retina, and their perfusion and interaction take place in the primary, secondary, and oligocentric visual cortical areas of the brain via ophthalmic neve.
    Previous studies have shown that various visual dysfunction begins in the early stages of degenerative brain diseases, including Alzheimer's, Parkinson's and multiple sclerosis. Among them, it has been reported that the threshold for yellow and blue recognition is higher, i.e., the sensitivity of color perception is less, which is thought to be the main cause of color recognition by red cone cells in the retina due to defects in the signaling process of green and blue cone cells that are responsible for wavelength recognition shorter than red. Color vision impact in Alzheimer's dementia has been reported since the early 2000s, and more specifically in the late 2000s, studies have been conducted on structural changes in the retina, such as RNFL thinning, and the correling of neurodegenation of visual pathways.
    However, this study is meaningful in that it wants to see the correlation between changes in sensitivity to a particular color and the retinal nerve fiber layer (RNFL) thinning, and the severity of dementia symptoms and the structural changes in the visual cortex on the Brain MRI. Systematization of this is expected to predict the progress of dementia and even the findings of Brain MRI before multiple tests are conducted by measuring the sensitivity changes to a particular color.
    
    2) Research hypothesis and purpose
    As cognitive degradation progresses in Alzheimer's dementia patients, cones cell degeneration of the retina will be reflected in increasing sensitivity to red. This increase in sensitivity will be correlated with a decrease in RNFL. In addition, the RNFL reduction would be related to the atrophy of the Brain Region (primary, secondary, oligopolical specific areas) associated with the color vision on the Brain MRI.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Cross-sectional  
    Target Number of Participant 100
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    cognitive decline group

    Cohort/Group Description

    As cognitive degradation progresses in Alzheimer's dementia patients, cones cell degeneration of the retina will be reflected in increasing sensitivity to red. This increase in sensitivity will be correlated with a decrease in RNFL. In addition, the RNFL reduction would be related to the atrophy of the Brain Region (primary, secondary, oligopolical specific areas) associated with the color vision on the Brain MRI.
    MMSE and CDR score will be used to observe cognitive decline and OCT, Ishihara 24 plate test will be conducted to measure RNFL thinning and color vision changes. We will also use Brain MRI to see the changes in the related Brain region.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who visit the psychiatry outpatient clinic with chief complaint of cognitive decline
    Sampling Method
    Among the patients who visit the psychiatry outpatient clinic with chief complaint of cognitive decline, a person who is suspected of Alzheimer's dementia and deemed necessary to evaluate MMSE-K and Brain MRI by a psychiatrist will be included. Non-probability sampling is used.
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F00.9)Dementia in Alzheimer´s disease, unspecified(G30.9†) 

    cognitive dysfunction, alzheimer disease
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    (1) A person who is suspected of Alzheimer's dementia in the opinion of a psychiatrist among patients who visit the psychiatry outpatient clinic with chief complaint of cognitive decline, and is deemed necessary to evaluate MME-K and Brain MRI.
    (2) the age of 65 or older
    Exclusion Criteria
    (1) Major mental disorders, such as bipolar disorder and schizophrenia;
    (2) Major degenerative diseases other than Alzheimer's (Parkinson's disease, vascular dementia, frontal lobe dementia, multiple sclerosis, etc.)
    (3) Patients with color blindness
    (4) A person with a past history of convulsions, head trauma, or substrate brain disease;
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Mini-Mental State Exam-Korea (MMSE-K), Clinical Dementia Rating (CDR), Geriatric Depression Scale (GDS), Ishihara 24 plate test
    Timepoint
    baseline
    Secondary Outcome(s) 1
    Outcome
    Optical Coherence Tomography (OCT), Brain MRI
    Timepoint
    within 6 months of baseline
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2026. 8
    Way of Sharing Available on Request
    (caunp@daum.net)
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