Abstract
BackgroundStroke 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/designThe 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.DiscussionPrevious 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.
Highlights
Stroke is the second most common cause of mortality and the leading cause of neurological disability, cognitive impairment and dementia worldwide
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
The results suggested that nimodipine could significantly delay the decrease in Sandoz clinical assessment geriatric scale (SCAG) score [Weighted mean difference (WMD) -11.75, 95% CI −15.64–-7.85, P < 0.00001] and clinical global impression (CGI) (WMD −1.31, 95% CI −1.73–-0.89, P
Summary
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. It is well established that stroke contributes to about 5.4 million deaths per year and is the leading cause of neurological disability worldwide [1,2]. Cognitive impairment and even post-stroke dementia can be induced by stroke. Cognitive impairment and dementia following stroke can severely lower the ability of perform daily activities and decrease quality of life (QOL) in patients with stroke, and increase the rate of disability and death. Prevention is crucial for both reduction of frequency of post-stroke cognitive decline and dementia and decreasing economic burden following stroke
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