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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT01220622
First received: October 12, 2010
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Stroke
Mild Cognitive Impairment
Drug: Nimodipine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)

Resource links provided by NLM:


Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 656
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nimodipine Drug: Nimodipine
Administration of nimodipine 30mg tid for 6 months
Other Name: Nimodiping Pian
Placebo Comparator: Placebo Drug: Placebo
Administration of placebo 30mg tid for 6 months
Other Name: Control group

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220622

Contacts
Contact: Feng tao, M.D. 00861067098343 happyft@sina.com
Contact: Wang xuemei, M.D. minnie_wxm@hotmail.com

Locations
China
Beijing Tian Tan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Feng tao, M.D.    00861067098343    happyft@sina.com   
Contact: Wang xuemei, M.D.       minnie_wxm@hotmail.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Yongjun Wang, Beijing Tian Tan Hospital, Capital Medical University, China
ClinicalTrials.gov Identifier: NCT01220622     History of Changes
Other Study ID Numbers: BSP-SOP-040
Study First Received: October 12, 2010
Last Updated: October 13, 2010
Health Authority: The people's republic of China: Giant Med-Pharma Service Group

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
Stroke
Mild cognitive impairment
Nimodipine

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cognition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nimodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 24, 2014