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

Phase 4

• Conditions: Stroke; Mild Cognitive Impairment
• Interventions: Drug: Nimodipine; Drug: Placebo

• Registration Number: NCT01220622
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

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 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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-13
• Last Update Submitted: 2010-10-13
• Study First Posted: 2010-10-14
• Last Update Posted: 2010-10-14
• Primary Completion: 2012-04
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 656

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nimodipine	Nimodipine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, China