Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes

Study Overview
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Brief Summary
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The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.

Detailed Description
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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.

Official Title
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Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)

Conditions
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Stroke, Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Nimodipine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subjects between 30 and 80 years. 2. ICD-10 and CT/MRI criteria for acute cerebral infarction. 3. Stroke within 7 days after onset. 4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others) 5. MoCA≤26 at baseline. 6.Hachinski ischemic score ≥7 at baseline. 7.Expected good compliance to study. 8.Informed consent signed. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nimodipine<br> | Drug: Nimodipine<br>* Administration of nimodipine 30mg tid for 6 months<br>* Other names: Nimodiping Pian;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administration of placebo 30mg tid for 6 months<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ADAS-cog and MMSE at 3 months in the ITT population |  | 3 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 1 month |  | 1 month | 
| The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Mild cognitive impairment, Nimodipine