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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01220622
• Date of registration: 12/10/2010
• Primary sponsor: Ministry of Science and Technology of the People´s Republic of China
• Public title: Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes NICE
• Scientific title: Nimodipine Preventing Cognitive Impairment in Ischemic Cerebrovascular Events: A Randomized, Placebo-Controlled, Double-Blind Trial (NICE)
• Date of first enrolment: October 2010
• Target sample size: 656
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01220622
• 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

Countries of recruitment

China

Contacts

• Name: Feng tao, M.D.

• Name: Feng tao, M.D.

• Name: Wang Yongjun, M.D.
• Affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Mild Cognitive Impairment

Stroke

Intervention(s)

Drug: Nimodipine

Drug: Placebo

Primary Outcome(s)

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(s)

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]

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]

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]

The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month [Time Frame: 1 month]

The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months [Time Frame: 3 months]

The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months [Time Frame: 6 months]

Secondary ID(s)

BSP-SOP-040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors