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

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ClinicalTrials.gov Identifier: NCT01220622
Recruitment Status : Unknown
Verified October 2010 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : October 14, 2010
Last Update Posted : October 14, 2010
Sponsor:
Information provided by:
Ministry of Science and Technology of the People´s Republic of China

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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Nimodipine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months [ Time Frame: 6 months ]
  3. 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 ]
  4. 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 ]
  5. The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month [ Time Frame: 1 month ]
  6. The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: October 2010

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
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents