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

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Nimodipine

Criteria

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.