title: Rationale and design of a double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of nimodipine in preventing cognitive impairment in ischemic cerebrovascular events (NICE).
abstract: BACKGROUND
  Stroke is the second most common cause of mortality and the leading cause of neurological disability, cognitive impairment and dementia worldwide. Nimodipine is a dihydropyridinic calcium antagonist with a role in neuroprotection, making it a promising therapy for vascular cognitive impairment and dementia.
  
  
  METHODS
  The NICE study is a multicenter, randomized, double-blind, placebo-controlled study being carried out in 23 centers in China. The study population includes patients aged 30-80 who have suffered an ischemic stroke (≤7 days). Participants are randomly allocated to nimodipine (90 mg/d) or placebo (90 mg/d). The primary efficacy is to evaluate the level of mild cognitive impairment following treatment of an ischemic stroke with nimodipine or placebo for 6 months. Safety is being assessed by observing side effects of nimodipine. Assuming a relative risk reduction of 22%, at least 656 patients are required in this study to obtain statistical power of 90%. The first patient was recruited in November 2010.
  
  
  CONCLUSIONS
  Previous studies suggested that nimodipine could improve cognitive function in vascular dementia and Alzheimer's disease dementia. It is unclear that at which time-point intervention with nimodipine should occur. Therefore, the NICE study is designed to evaluate the benefits and safety of nimodipine, which was adminstered within seven days, in preventing/treating mild cognitive impairment following ischemic stroke.
authors.affiliation: Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
authors.forename: Penglian
authors.initials: P
authors.lastname: Wang
authors.forename: Yongjun
authors.initials: Y
authors.lastname: Wang
authors.forename: Tao
authors.initials: T
authors.lastname: Feng
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhou
authors.forename: Yilong
authors.initials: Y
authors.lastname: Wang
authors.forename: Weixiong
authors.initials: W
authors.lastname: Shi
authors.forename: Yi
authors.initials: Y
authors.lastname: Ju
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000150:complications* / Q000188:drug therapy*; D003072:Cognition Disorders / Q000209:etiology* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009553:Nimodipine / Q000009:adverse effects* / Q000627:therapeutic use*; D015990:Placebo Effect; D012107:Research Design; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D014665:Vasodilator Agents; D009553:Nimodipine