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

Vascular Dementia Clinical Trial

— SMCZN01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01466543
• Other study ID #: SMC 2011-05-042
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 3, 2011
• Last updated: November 7, 2011
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2011
• Source: Samsung Medical Center
• Contact: Hyunhee Jung, BSc
• Phone: 82-2-3410-6830
• Email: napapaya[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Subcortical Vascular Dementia
• Vascular Dementia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow	Measured by Near-infrared spectroscopy (NIRS)	One hour after the administration of the medication	No
Secondary	Peripheral blood viscosity	Measured from whole blood	One hour after the administration of the medication	No