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

Primary Purpose

Stroke, Mild Cognitive Impairment

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nimodipine
Placebo
Sponsored by
Ministry of Science and Technology of the People´s Republic of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Mild cognitive impairment, Nimodipine

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nimodipine

Placebo

Arm Description

Outcomes

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

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
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 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
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months

Full Information

First Posted
October 12, 2010
Last Updated
October 13, 2010
Sponsor
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT01220622
Brief Title
Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes
Acronym
NICE
Official Title
Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Mild Cognitive Impairment
Keywords
Stroke, Mild cognitive impairment, Nimodipine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
656 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimodipine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nimodipine
Other Intervention Name(s)
Nimodiping Pian
Intervention Description
Administration of nimodipine 30mg tid for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control group
Intervention Description
Administration of placebo 30mg tid for 6 months
Primary Outcome Measure Information:
Title
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population
Time Frame
6 months
Title
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months
Time Frame
6 months
Title
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
Time Frame
3 months
Title
Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population
Time Frame
3 months
Title
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month
Time Frame
1 month
Title
The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng tao, M.D.
Phone
00861067098343
Email
happyft@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang xuemei, M.D.
Email
minnie_wxm@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Yongjun, M.D.
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng tao, M.D.
Phone
00861067098343
Email
happyft@sina.com
First Name & Middle Initial & Last Name & Degree
Wang xuemei, M.D.
Email
minnie_wxm@hotmail.com

12. IPD Sharing Statement

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

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