Status:
UNKNOWN
Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes
Lead Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Stroke
Mild Cognitive Impairment
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
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
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 exclusio...
Eligibility Criteria
Inclusion
- 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.
- based on years of education correction.MMSE\>17(illiteracy),MMSE\>20(primary school),MMSE\>24(others)
- 5\. MoCA≤26 at baseline.
- Hachinski ischemic score ≥7 at baseline.
- Expected good compliance to study.
- Informed consent signed.
Exclusion
- Diagnosis of schizophrenia, major anxiety syndrome, major depression.
- Alzheimer disease, Parkinson disease, Huntington disease, and fronto-temporal dementia.
- 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).
- Contraindications to dihydropyridine derivatives.
- Aphasia or other diseases that affect cognitive evaluation.
- 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.
- History of epilepsy, use of the antiepileptic drugs.
- CT/MRI showed neurodegenerative changes or other lesions except cerebral ischemia.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT01220622
Start Date
October 1 2010
End Date
July 1 2012
Last Update
October 14 2010
Active Locations (1)
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1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, China