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":"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}
引用次数: 0
Abstract
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.