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| Name | Class |
|---|---|
| Dong-A Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.
Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor (PDE5i). Since PDE5i is known to relax smooth muscle cells, it is suggested that PDE5i may dilate cerebral vessels and lead to an increase in cerebral blood flow. The main mechanism of subcortical vascular cognitive impairment are hypoperfusion of the brain. Therefore, in this study, the investigators will investigate whether Udenafil can increase cerebral blood flow and also lower peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zydena (Udenafil) | Active Comparator | Zydena (Udenafil) 100 mg, once |
|
| Placebo | Placebo Comparator | placebo medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zydena (Udenafil) | Drug | Zydena (Udenafil) 100 mg, one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow | Measured by Near-infrared spectroscopy (NIRS) | One hour after the administration of the medication |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood viscosity | Measured from whole blood | One hour after the administration of the medication |
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Inclusion Criteria:
for Normal control group
for Subcortical vascular mild cognitive impairment (svMCI)
Exclusion Criteria:
- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyunhee Jung, BSc | Contact | 82-2-3410-6830 | 6830 | napapaya@hanmail.net |
| Duk L. Na, MD. PhD | Contact | 82-2-3410-3599 | 3599 | dukna@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Duk L. Na, MD. PhD. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| Placebo | Drug | Placebo |
|
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |