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

Stroke Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01220622
• Other study ID #: BSP-SOP-040
• Status: Recruiting
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: October 13, 2010
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2010
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: Feng tao, M.D.
• Phone: 00861067098343
• Email: happyft[@]sina.com
• Is FDA regulated: No
• Health authority: The people's republic of China: Giant Med-Pharma Service Group
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Stroke

Intervention

Drug:
• Nimodipine
Administration of nimodipine 30mg tid for 6 months
• Placebo
Administration of placebo 30mg tid for 6 months

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months		6 months	No
Secondary	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	No
Secondary	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	No
Secondary	The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month		1 month	No
Secondary	The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months		3 months	No