4.6 Article

The efficacy and safety of nimodipine in acute ischemic stroke patients with mild cognitive impairment: a double-blind, randomized, placebo-controlled trial

期刊

SCIENCE BULLETIN
卷 64, 期 2, 页码 101-107

出版社

ELSEVIER
DOI: 10.1016/j.scib.2018.12.006

关键词

Nimodipine; Acute ischemic stroke; Mild cognitive impairment; Cognitive decline; Prevention

资金

  1. National 11th & 12th Five Year S & T Major Projects [2011BAI08B01, 2011BAI08B02]
  2. Ministry of Science and Technology of China [2012ZX09303-005-001, 2013BAI09B03]
  3. Beijing Biobank of Cerebral Vascular Disease [D131100005313003]

向作者/读者索取更多资源

Nimodipine might be effective in subcortical vascular dementia (VaD). Its benefit in preventing further cognitive decline in patients with acute ischemic stroke (AIS) and vascular mild cognitive impairment (VaMCI) remains to be established. In this multicenter, double-blind trial, we randomly assigned 654 eligible patients to nimodipine 30 mg three times a day or placebo. The primary outcome was any cognitive decline defined by the changes on the Mini-Mental State Examination (Delta MMSE <=-3) or vascular AD assessment scale cognitive subscale (Delta ADAS-cog >= 4) at 6 months. Secondary outcomes included any distribution shift of Delta ADAS-cog, Delta MMSE or cognitive improvement defined by Delta ADAS-cog <=-2, or Delta MMSE >= 0. The primary outcome in the nimodipine group and placebo group were similar for Delta MMSE <=-3 (4.18% and 7.22%, respectively, P = 0.15) and Delta ADAS-cog >= 4 (8.36% and 8.93% respectively, P = 0.88). The distribution shift of Delta ADAS-cog and Delta MMSE differed significantly between the two groups (P = 0.03 and P = 0.05 respectively). Cognitive improvement occurred in 55.4% in the nimodipine group and 43.6% in the placebo group measured by Delta ADAS-cog <=-2 (Odds Ratio, 1.54; 95% confidence interval [CI] 1.10-2.14, P < 0.01) or 84.0% and 74.6% respectively by Delta MMSE >= 0 (Odds Ratio, 1.79; 95% CI 1.18-2.70, P < 0.01). Nimodipine was associated with better cognitive function in the memory domain. The adverse events rate was similar in two groups. This study is registered with ClinicalTrials.gov, NCT01220622. Nimodipine did not show benefit to prevent cognitive decline in AIS patients with VaMCI, but improved cognition moderately, especially measured in the memory domain. (C) 2018 Science China Press. Published by Elsevier B.V. and Science China Press. All rights reserved.

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