NCT01220622Unknown4 期
Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
Ministry of Science and Technology of the People´s Republic of China1 个研究点 分布在 1 个国家目标入组 656 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 656
- 试验地点
- 1
- 主要终点
- Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population
研究概览
简要总结
The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.
详细描述
656 patients diagnosed with acute cerebral ischemia disease (onset≤7d) based on ICD-10 and CT/MRI criteria, who have cognitive impairment meeting all of the inclusion criteria and none of the exclusion criteria, will be included and randomized into nimodipine treatment group and the controlled group.Evaluations of cognitive function will be taken at baseline, 1 month, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 30 and 80 years.
- •ICD-10 and CT/MRI criteria for acute cerebral infarction.
- •Stroke within 7 days after onset.
- •4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others)
- •MoCA≤26 at baseline.
- •6.Hachinski ischemic score ≥7 at baseline.
- •7.Expected good compliance to study.
- •8.Informed consent signed.
排除标准
- •1.Diagnosis of schizophrenia, major anxiety syndrome, major depression.
- •2.Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia.
- •3.Dementia caused by (e.g., central nervous system trauma, tumor, infections, metabolic disorders, normal pressure hydrocephalus, lack of folic acid or vitamin B12, or thyroid hormone deficiency).
- •4.Contraindications to dihydropyridine derivatives.
- •5.Aphasia or other diseases that affect cognitive evaluation.
- •6.Serious arrhythmias, bradycardia (<50 bpm) or tachycardia (>120 bpm); myocardial infarction within the past 6 months; blood pressure <90/60mmHg; severe renal or hepatic insufficiency; severe anemia, Hb<100g/L; severe gastrointestinal disorders; tumor.
- •7.History of epilepsy, use of the antiepileptic drugs.
- •8.CT/MRI showed neurodegenerative changes or other lesions except cerebral ischemia.
研究组 & 干预措施
Nimodipine
Active Comparator
干预措施: Nimodipine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 6 months in the ITT population
时间窗: 6 months
次要结局
- Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with ADAS-cog and MMSE at 3 months in the ITT population(3 months)
- The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month(1 month)
- Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population(6 months)
- The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months(6 months)
- Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population(3 months)
- The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months(3 months)
研究者
研究点 (1)
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