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
Recruitment status was Recruiting
Sponsor:
Ministry of Science and Technology of the People´s Republic of China
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
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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
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 June 17, 2013