Jae-Sung Lim, Joung-Ho Rha, Jong-Ho Park, Kyungbok Lee, Dae-Il Chang, Sung Hyuk Heo, Yeong Bae Lee, Jee-Hyun Kwon, Eung-Gyu Kim, Jay Chol Choi, Man-Seok Park, Kyung-Hee Cho, Jae-Kwan Cha, Mi Sun Oh, Byung-Chul Lee, Hahn Young Kim, Kyungmi Oh, Hyun-Young Park, Sanghak Yi, Tai Hwan Park, Jae-Hyeok Heo, Keun-Hwa Jung, Chulho Kim, Soo Joo Lee, Jae Guk Kim, Dong-Eog Kim, Jong-Moo Park, Kyusik Kang, Jun Hong Lee, Jong-Won Chung, Kwang-Yeol Park, Won-Jin Moon, Hyuntae Park, Seongryu Bae, Yeonwook Kang, Hannah Jung, Juneyoung Lee, Hee-Joon Bae
{"title":"奥拉西坦和体力活动预防脑卒中后认知能力下降:一项多中心随机对照试验。","authors":"Jae-Sung Lim, Joung-Ho Rha, Jong-Ho Park, Kyungbok Lee, Dae-Il Chang, Sung Hyuk Heo, Yeong Bae Lee, Jee-Hyun Kwon, Eung-Gyu Kim, Jay Chol Choi, Man-Seok Park, Kyung-Hee Cho, Jae-Kwan Cha, Mi Sun Oh, Byung-Chul Lee, Hahn Young Kim, Kyungmi Oh, Hyun-Young Park, Sanghak Yi, Tai Hwan Park, Jae-Hyeok Heo, Keun-Hwa Jung, Chulho Kim, Soo Joo Lee, Jae Guk Kim, Dong-Eog Kim, Jong-Moo Park, Kyusik Kang, Jun Hong Lee, Jong-Won Chung, Kwang-Yeol Park, Won-Jin Moon, Hyuntae Park, Seongryu Bae, Yeonwook Kang, Hannah Jung, Juneyoung Lee, Hee-Joon Bae","doi":"10.1177/23969873251350141","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea's Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.</p><p><strong>Patients and methods: </strong>Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.</p><p><strong>Results: </strong>Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; <i>p</i> = 0.49) or CDR-SB scores (-0.14 ± 0.70 vs -0.08 ± 0.80; <i>p</i> = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.</p><p><strong>Discussion and conclusion: </strong>Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":" ","pages":"23969873251350141"},"PeriodicalIF":4.5000,"publicationDate":"2025-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12303921/pdf/","citationCount":"0","resultStr":"{\"title\":\"Oxiracetam and physical activity in preventing cognitive decline after stroke: A multicenter, randomized controlled trial.\",\"authors\":\"Jae-Sung Lim, Joung-Ho Rha, Jong-Ho Park, Kyungbok Lee, Dae-Il Chang, Sung Hyuk Heo, Yeong Bae Lee, Jee-Hyun Kwon, Eung-Gyu Kim, Jay Chol Choi, Man-Seok Park, Kyung-Hee Cho, Jae-Kwan Cha, Mi Sun Oh, Byung-Chul Lee, Hahn Young Kim, Kyungmi Oh, Hyun-Young Park, Sanghak Yi, Tai Hwan Park, Jae-Hyeok Heo, Keun-Hwa Jung, Chulho Kim, Soo Joo Lee, Jae Guk Kim, Dong-Eog Kim, Jong-Moo Park, Kyusik Kang, Jun Hong Lee, Jong-Won Chung, Kwang-Yeol Park, Won-Jin Moon, Hyuntae Park, Seongryu Bae, Yeonwook Kang, Hannah Jung, Juneyoung Lee, Hee-Joon Bae\",\"doi\":\"10.1177/23969873251350141\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea's Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.</p><p><strong>Patients and methods: </strong>Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.</p><p><strong>Results: </strong>Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; <i>p</i> = 0.49) or CDR-SB scores (-0.14 ± 0.70 vs -0.08 ± 0.80; <i>p</i> = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.</p><p><strong>Discussion and conclusion: </strong>Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.</p>\",\"PeriodicalId\":46821,\"journal\":{\"name\":\"European Stroke Journal\",\"volume\":\" \",\"pages\":\"23969873251350141\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2025-07-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12303921/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Stroke Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/23969873251350141\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Stroke Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/23969873251350141","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
这项多中心、双盲、安慰剂对照试验由韩国食品和药物安全部委托进行,评估了奥拉西坦预防脑卒中后认知障碍(PSCI)的效果,并利用神经成像技术探讨了奥拉西坦与体育活动的潜在相互作用。患者和方法:卒中后报告主观认知能力下降大于或等于3个月的PSCI高风险患者按1:1随机分配,接受奥拉西坦或安慰剂治疗36周。身体活动通过腕式活动记录仪进行跟踪。主要终点是迷你精神状态检查(MMSE)和临床痴呆评分-盒和(CDR-SB)的变化。次要结果包括神经心理学评估和静息状态功能磁共振成像网络指标。结果:500名参与者(平均年龄68.9岁,中位中风后32个月)中,457人完成了研究。两组患者MMSE(奥拉西坦:+0.13±2.27 vs安慰剂:+0.27±2.09;p = 0.49)或CDR-SB评分(-0.14±0.70 vs -0.08±0.80;p = 0.38)的变化无统计学差异。没有证据表明奥拉西坦与体力活动之间存在相互作用。探索性分析表明,在高活性奥拉西坦参与者中,功能分离和CDR-SB评分有良好的趋势。讨论与结论:奥拉西坦在预防高危患者PSCI方面没有显示出益处。这些发现支持了最近监管部门暂停在韩国使用该药物的决定。
Oxiracetam and physical activity in preventing cognitive decline after stroke: A multicenter, randomized controlled trial.
Introduction: This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea's Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.
Patients and methods: Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.
Results: Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; p = 0.49) or CDR-SB scores (-0.14 ± 0.70 vs -0.08 ± 0.80; p = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.
Discussion and conclusion: Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.
期刊介绍:
Launched in 2016 the European Stroke Journal (ESJ) is the official journal of the European Stroke Organisation (ESO), a professional non-profit organization with over 1,400 individual members, and affiliations to numerous related national and international societies. ESJ covers clinical stroke research from all fields, including clinical trials, epidemiology, primary and secondary prevention, diagnosis, acute and post-acute management, guidelines, translation of experimental findings into clinical practice, rehabilitation, organisation of stroke care, and societal impact. It is open to authors from all relevant medical and health professions. Article types include review articles, original research, protocols, guidelines, editorials and letters to the Editor. Through ESJ, authors and researchers have gained a new platform for the rapid and professional publication of peer reviewed scientific material of the highest standards; publication in ESJ is highly competitive. The journal and its editorial team has developed excellent cooperation with sister organisations such as the World Stroke Organisation and the International Journal of Stroke, and the American Heart Organization/American Stroke Association and the journal Stroke. ESJ is fully peer-reviewed and is a member of the Committee on Publication Ethics (COPE). Issues are published 4 times a year (March, June, September and December) and articles are published OnlineFirst prior to issue publication.