Email updates

Keep up to date with the latest news and content from BMC Neurology and BioMed Central.

Open Access Study protocol

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)

Penglian Wang, Yongjun Wang*, Tao Feng*, Xingquan Zhao, Yong Zhou, Yilong Wang, Weixiong Shi, Yi Ju and on behalf of the NICE Study Investigators

Author Affiliations

Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

For all author emails, please log on.

BMC Neurology 2012, 12:88  doi:10.1186/1471-2377-12-88

Published: 5 September 2012

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/design

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.

Discussion

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.