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

Sponsor

Ministry of Science and Technology of the People´s Republic of China (Other)

Overall Status

Unknown status

CT.gov ID

NCT01220622

Collaborator

(none)

656

Enrollment

Location

Arms

Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Mild Cognitive Impairment	Drug: Nimodipine Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

656 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nimodipine	Drug: Nimodipine Administration of nimodipine 30mg tid for 6 months Other Names: Nimodiping Pian
Placebo Comparator: Placebo	Drug: Placebo Administration of placebo 30mg tid for 6 months Other Names: Control group

Arm

Intervention/Treatment

Active Comparator: Nimodipine

Drug: Nimodipine

Administration of nimodipine 30mg tid for 6 months

Other Names:

Nimodiping Pian

Placebo Comparator: Placebo

Drug: Placebo

Administration of placebo 30mg tid for 6 months

Other Names:

Control group

Outcome Measures

Primary Outcome Measures

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

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 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 3 months in the ITT population [3 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Subjects between 30 and 80 years.
1. ICD-10 and CT/MRI criteria for acute cerebral infarction.
1. Stroke within 7 days after onset.
4.based on years of education correction.MMSE>17(illiteracy),MMSE>20(primary school),MMSE>24(others)
1. 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.