NCT01872858Unknown不适用
Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- changes in cognitive function
研究概览
简要总结
Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 50-80, both gender；
- •Small vessel disease and associated cognitive impairment, diagnosed as VCIND；
- •Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.
- •Normal hepatic and renal function.
- •With good compliance.
排除标准
- •Aged above 80 or less than
- •Cerebral infarction(>2cm).
- •Major vascular lesion. (stenosis>50%).
- •Cardiac cerebral infarction.
- •Intracerebral Hemorrhage.
- •Clinical manifestations cannot attribute to small vessel disease.
- •Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.
- •Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).
- •Thrombocytopenic Purpura.
- •History of hemorrhage in digestive system or surgery in past 3 months.
- •Previously on cilostazol treatment for more than 3 month.
- •Allergic to aspirin or cilostazol.
- •Enrolled in other clinical trials in past 3 months.
- •Lack of informed consent or compliance.
- •Contraindications for MRI scan.
研究组 & 干预措施
Aspirin
Active Comparator
Aspirin, 100mg, Q.D, p.o, 2yr
干预措施: Aspirin (Drug)
Cilostazol
Experimental
cilostazol, 100mg, B.I.D, p.o, 2yr
干预措施: Cilostazol (Drug)
结局指标
主要结局
changes in cognitive function
时间窗: baseline, 3month, 6month, 1year, and 2year
scores in Montreal Cognitive Assessment，Mini-Mental Status Examination, Clinal Dementia Rating，trail making test, similarity test, Stroop test.
次要结局
- Number of Participants with Incident cerebral vascular event(3month, 6month, 1year and 2year)
- Changes of peripheral inflammatory markers level(baseline, 2year)
- The progression of cerebral white matter lesion and lacunar infarction(baseline, 3month, 6month, 1year and 2year)
- changes in MRI-diffused tension image(DTI)(baseline, 2year)
研究者
Jianhui Fu
Department of Neurology, Huashan Hospital
Huashan Hospital
研究点 (1)
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