Mild Cognitive Impairment, Stroke
Conditions
Keywords
Stroke, Mild cognitive impairment, Nimodipine
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.
Interventions
DRUGNimodipine
Administration of nimodipine 30mg tid for 6 months
DRUGPlacebo
Administration of placebo 30mg tid for 6 months
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 6 months in the ITT population | 6 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 |
| 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 |
Countries
China
Contacts
Primary ContactFeng tao, M.D.
Backup ContactWang xuemei, M.D.
Outcome results
None listed