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
CRIS Registration Number |
KCT0005606 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Chung-Ang Univerisity Hospital |
Organization Type | Medical Institute |
Project ID | 1922-015-400 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chung-Ang Univerisity Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Patients who visit the psychiatry outpatient clinic with chief complaint of cognitive decline |
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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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Mini-Mental State Exam-Korea (MMSE-K), Clinical Dementia Rating (CDR), Geriatric Depression Scale (GDS), Ishihara 24 plate test |
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Timepoint | baseline |
|
Secondary Outcome(s) 1 | ||
Outcome | Optical Coherence Tomography (OCT), Brain MRI |
|
Timepoint | within 6 months of baseline |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2026. 8 |
Way of Sharing | Available on Request
(caunp@daum.net) |
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