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

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

The trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on cognition impairment after acute ischemic stroke.

Study Overview

• Status: Unknown
• Conditions: Stroke; Mild Cognitive Impairment
• Intervention / Treatment: Drug: Nimodipine; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 656
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tian Tan Hospital, Capital Medical University
    • Contact: Feng tao, M.D.; Phone Number: 00861067098343; Email: happyft@sina.com
    • Contact: Wang xuemei, M.D.; Email: minnie_wxm@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Principal Investigator: Wang Yongjun, M.D., Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Stroke; Mild cognitive impairment; Nimodipine
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Nimodipine
• Other Study ID Numbers: BSP-SOP-040