Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects

Conditions
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Vascular Dementia, Subcortical Vascular Dementia

Intervention / Treatment
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* Drug: Zydena (Udenafil)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: for Normal control group Normal cognition by detailed neuropsychological tests Brain MRI scan with no or minimal white matter hyperintensities for Subcortical vascular mild cognitive impairment (svMCI) Clinical diagnosis of svMCI Brain MRI scan with severe white matter hyperintensities Exclusion Criteria: - Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zydena (Udenafil)<br>Zydena (Udenafil) 100 mg, once | Drug: Zydena (Udenafil)<br>* Zydena (Udenafil) 100 mg, one time<br>* Other names: Udenafil;|
| Placebo Comparator: Placebo<br>placebo medication | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow | Measured by Near-infrared spectroscopy (NIRS) | One hour after the administration of the medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood viscosity | Measured from whole blood | One hour after the administration of the medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil