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

Overview

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.

Full Title of Study: “Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

Detailed Description

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.

Interventions

  • Drug: Zydena (Udenafil)
    • Zydena (Udenafil) 100 mg, one time
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Active Comparator: Zydena (Udenafil)
    • Zydena (Udenafil) 100 mg, once
  • Placebo Comparator: Placebo
    • placebo medication

Clinical Trial Outcome Measures

Primary Measures

  • Cerebral blood flow
    • Time Frame: One hour after the administration of the medication
    • Measured by Near-infrared spectroscopy (NIRS)

Secondary Measures

  • Peripheral blood viscosity
    • Time Frame: One hour after the administration of the medication
    • Measured from whole blood

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Collaborator
    • Dong-A Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Duk Lyul Na, Professor – Samsung Medical Center
  • Overall Official(s)
    • Duk L. Na, MD. PhD., Principal Investigator, Samsung Medical Center
  • Overall Contact(s)
    • Hyunhee Jung, BSc, 82-2-3410-6830, napapaya@hanmail.net

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