Vascular DementiaPhase 2SMCZN01NCT01466543
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity
A Phase 2 study testing Zydena (Udenafil) in people with Vascular Dementia and Subcortical Vascular Dementia, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Dementia, Subcortical Vascular Dementia
- What is being tested?
- Zydena (Udenafil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, 135-710
Hyunhee Jung, BSc, 82-2-3410-6830 ext. 6830, napapaya@hanmail.net
About this study
Official title: Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
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.
Read the 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.
- Conditions
- Vascular Dementia, Subcortical Vascular Dementia
- Being tested
- Zydena (Udenafil), Placebo
- Keywords
- Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zydena (Udenafil)Drug
Also called Zydena, Udenafil
Zydena (Udenafil) 100 mg, one time
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Zydena (Udenafil) | Active comparator | Zydena (Udenafil) 100 mg, once Receives: Drug: Zydena (Udenafil) |
| Placebo | Placebo comparator | placebo medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Measured by Near-infrared spectroscopy (NIRS)
Measured: One hour after the administration of the medication
Secondary outcomes (1)
Peripheral blood viscosity
Measured from whole blood
Measured: One hour after the administration of the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Duk Lyul Na, Samsung Medical Center
- Investigators
- Duk L. Na, MD. PhD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466543
- Sponsor's protocol ID
- SMC 2011-05-042
- Acronym
- SMCZN01
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
- ClinicalTrials.gov ID
- NCT01466543
- Acronym / sponsor ID
- SMCZN01 / SMC 2011-05-042
- Conditions
- Vascular Dementia, Subcortical Vascular Dementia
- Keywords
- Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zydena (Udenafil) | Active comparator | Drug: Zydena (Udenafil)Zydena (Udenafil) 100 mg, once |
| Placebo | Placebo comparator | Drug: Placeboplacebo medication |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zydena (Udenafil)Also: Zydena, UdenafilZydena (Udenafil) 100 mg, one time | Drug | Zydena (Udenafil) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cerebral blood flow
Time frame: One hour after the administration of the medication
Measured by Near-infrared spectroscopy (NIRS)
1 secondary outcome
Peripheral blood viscosity
Time frame: One hour after the administration of the medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk L. Na, MD. PhD. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zydena (Udenafil) in people with Vascular Dementia and Subcortical Vascular Dementia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyunhee Jung, BSc (82-2-3410-6830 ext. 6830, napapaya@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: One hour after the administration of the medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.