NCT01466543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

4 months

First QC Date

November 3, 2011

Last Update Submit

November 7, 2011

Conditions

Vascular DementiaSubcortical Vascular Dementia

Keywords

Vascular dementiaSubcortical vascular dementiaPhosphodiesterase 5Udenafil

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    Measured by Near-infrared spectroscopy (NIRS)

    One hour after the administration of the medication

Secondary Outcomes (1)

  • Peripheral blood viscosity

    One hour after the administration of the medication

Study Arms (2)

Zydena (Udenafil)

ACTIVE COMPARATOR

Zydena (Udenafil) 100 mg, once

Drug: Zydena (Udenafil)

Placebo

PLACEBO COMPARATOR

placebo medication

Drug: Placebo

Interventions

Zydena (Udenafil)DRUG

Zydena (Udenafil) 100 mg, one time

Also known as: Zydena, Udenafil
Zydena (Udenafil)
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Dementia, Vascular

Interventions

udenafil

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesDementiaLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Duk L. Na, MD. PhD.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyunhee Jung, BSc

CONTACT

82-2-3410-6830napapaya@hanmail.net

Duk L. Na, MD. PhD

CONTACT

82-2-3410-3599dukna@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

November 1, 2012

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

KR(1)