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This clinical trial aims to explore the effectiveness and safety of cognitive function improvement of Neuclare, a science medical device, for patients with mild cognitive impairment and early Alzheimer's disease.
Through methods such as Trail Making Test Black & White, Attention Questionnaire Scale(AQS), Neuropsychiatric Inventory (NPI), etc, cognitive function improvement before and after using Neuclare will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuclare | Device | It is used to stimulate the brain for a certain period of time to improve cognitive impairment in patients with cognitive disorder. In this clinical trial, it is used for patients with mild cognitive disorder and demincia symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Trail Making Test Black & White Score : From Baseline to Week 5 | Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Trail Making Test Black & White Score | Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Attention Questionnaire Scale : From Baseline to Week 5 | Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Attention Questionnaire Scale | Week 5 |
| Change of Neuropsychiatric Inventory Score : From Baseline to Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seonkyu Kim | Contact | +82-10-4324-5147 | ksksbs@deepsonbio.com |
| Name | Affiliation | Role |
|---|---|---|
| SangYun Kim, M.D. ph.D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Neuropsychiatric Inventory score |
| Week 5 |
| Change of Quality of life-AD Score : From Baseline to Week 5 | Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Quality of life-AD Score | Week 5 |
| Change of MMSE-II Score : From Baseline to Week 5 | Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by MMSE-II Score | Week 5 |
| change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5 | change of beta-amyloid deposition with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by Amyloid PET-CT | Week 5 |
| Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5 | Compare glucose metabolic rate with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by FDG PET-CT | Week 5 |
| Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5 | Compare Aβ oligomer density with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by MDS-OAβ test | Week 5 |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |