Clinical trial NCT01220622: Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes
Official title: Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Mild Cognitive Impairment
Keywords: Stroke
Mild cognitive impairment
Nimodipine
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2010-10-14
Enrollment: 656
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population
timeFrame: 6 months
measure: The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months
timeFrame: 6 months
measure: 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
timeFrame: 3 months
measure: Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population
timeFrame: 3 months
measure: The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month
timeFrame: 1 month
measure: The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Wang Yongjun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: