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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01466543

Acronym

SMCZN01

Enrollment

Registered

2011-11-08

Start date

2011-11-30

Completion date

2012-11-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subcortical Vascular Dementia, Vascular Dementia

Keywords

Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil

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.

Interventions

DRUGZydena (Udenafil)

Zydena (Udenafil) 100 mg, one time

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Peripheral blood viscosity	One hour after the administration of the medication	Measured from whole blood

Countries

South Korea

Contacts

Primary ContactHyunhee Jung, BSc

napapaya@hanmail.net82-2-3410-6830

Backup ContactDuk L. Na, MD. PhD

dukna@naver.com82-2-3410-3599

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026