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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01466543
• Collaborator: Dong-A Pharmaceutical Co., Ltd. (Industry)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Dementia; Subcortical Vascular Dementia	Drug: Zydena (Udenafil); Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Mar 1, 2012
• Anticipated Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Zydena (Udenafil) Zydena (Udenafil) 100 mg, once	Drug: Zydena (Udenafil); Zydena (Udenafil) 100 mg, one time; Other Names: Zydena Udenafil
Placebo Comparator: Placebo placebo medication	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Cerebral blood flow [One hour after the administration of the medication]

   Measured by Near-infrared spectroscopy (NIRS)

Secondary Outcome Measures

1. Peripheral blood viscosity [One hour after the administration of the medication]

   Measured from whole blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center
• Dong-A Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Duk L. Na, MD. PhD., Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duk Lyul Na, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01466543
• Other Study ID Numbers: SMC 2011-05-042
• First Posted: Nov 8, 2011
• Last Update Posted: Nov 8, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Duk Lyul Na, Professor, Samsung Medical Center: Vascular dementia; Subcortical vascular dementia; Phosphodiesterase 5; Udenafil
• Additional relevant MeSH terms: Dementia; Dementia, Vascular; Udenafil

Study Results

No Results Posted as of Nov 8, 2011