Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cerebral blood flow
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
研究组 & 干预措施
Zydena (Udenafil)
Zydena (Udenafil) 100 mg, once
干预措施: Zydena (Udenafil) (Drug)
Placebo
placebo medication
干预措施: Placebo (Drug)
结局指标
主要结局
Cerebral blood flow
时间窗: One hour after the administration of the medication
Measured by Near-infrared spectroscopy (NIRS)
次要结局
- Peripheral blood viscosity(One hour after the administration of the medication)
研究者
Duk Lyul Na
Professor
Samsung Medical Center