Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity (SMCZN01)

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Vascular Dementia; Subcortical Vascular Dementia

Treatments: Drug: Zydena (Udenafil); Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01466543

SMC 2011-05-042

Details and patient eligibility

About

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Zydena (Udenafil)

Active Comparator group

Description:

Zydena (Udenafil) 100 mg, once

Treatment:

Drug: Zydena (Udenafil)

Placebo

Placebo Comparator group

Description:

placebo medication

Treatment:

Drug: Placebo