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

Recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Nimodipine (Nimotop®)Drug
    Intervention Desc: Administration of nimodipine 30mg tid for 6 months
    ARM 1: Kind: Experimental
    Label: Nimodipine
  • Placebo Drug
    Intervention Desc: Administration of placebo 30mg tid for 6 months
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 6 months No
Secondary Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 6 months in the ITT population 6 months No
Secondary The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 6 months 6 months No
Secondary 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 3 months No
Secondary Assess the effect of nimodipine on the cognitive function after acute cerebral ischemia with MoCA and FAB at 3 months in the ITT population 3 months No
Secondary The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 1 month 1 month No
Secondary The prevalence of possible vascular dementia diagnosed by NINDS-AIREN criteria at 3 months 3 months No

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