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

Phase 2

• Conditions: Vascular Dementia; Subcortical Vascular Dementia
• Interventions: Drug: Zydena (Udenafil); Drug: Placebo

• Registration Number: NCT01466543
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-07
• Last Update Submitted: 2011-11-07
• Study First Posted: 2011-11-08
• Last Update Posted: 2011-11-08
• Primary Completion: 2012-03
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zydena (Udenafil)	Zydena (Udenafil)	Zydena (Udenafil) 100 mg, once
Placebo	Placebo	placebo medication

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peripheral blood viscosity	One hour after the administration of the medication	Measured from whole blood

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of