Efficacy and safety of oxiracetam in patients with vascular cognitive impairment: A multicenter, randomized, double-blinded, placebo-controlled, phase IV clinical trial
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dc.contributor.author | Lim, Jae -Sung | - |
dc.contributor.author | Lee, Juneyoung | - |
dc.contributor.author | Kang, Yeonwook | - |
dc.contributor.author | Park, Hyun-Tae | - |
dc.contributor.author | Kim, Dong-Eog | - |
dc.contributor.author | Cha, Jae-Kwan | - |
dc.contributor.author | Park, Tai Hwan | - |
dc.contributor.author | Heo, Jae-Hyuk | - |
dc.contributor.author | Lee, Kyung Bok | - |
dc.contributor.author | Park, Jong -Moo | - |
dc.contributor.author | Oh, Mi Sun | - |
dc.contributor.author | Kim, Eung-Gyu | - |
dc.contributor.author | Chang, Dae-Il | - |
dc.contributor.author | Heo, Sung Hyuk | - |
dc.contributor.author | Park, Man-Seok | - |
dc.contributor.author | Park, HyunYoung | - |
dc.contributor.author | Yi, SangHak | - |
dc.contributor.author | Lee, Yeong Bae | - |
dc.contributor.author | Park, Kwang-Yeol | - |
dc.contributor.author | Lee, Soo Joo | - |
dc.contributor.author | Kim, Jae Guk | - |
dc.contributor.author | Lee, Jun | - |
dc.contributor.author | Cho, Kyung-Hee | - |
dc.contributor.author | Rha, Joung-Ho | - |
dc.contributor.author | Kim, Yeong-In | - |
dc.contributor.author | Lee, Jun Hong | - |
dc.contributor.author | Choi, Jay Chol | - |
dc.contributor.author | Oh, Kyung-Mi | - |
dc.contributor.author | Kwon, Jee-Hyun | - |
dc.contributor.author | Kim, Chulho | - |
dc.contributor.author | Park, Jong-Ho | - |
dc.contributor.author | Jung, Keun-Hwa | - |
dc.contributor.author | Sung, Sang Min | - |
dc.contributor.author | Chung, Jong-Won | - |
dc.contributor.author | Lee, Yong-Seok | - |
dc.contributor.author | Kim, Hahn Young | - |
dc.contributor.author | Cho, Hyun-Ji | - |
dc.contributor.author | Park, Jeong Wook | - |
dc.contributor.author | Moon, Won-Jin | - |
dc.contributor.author | Bae, Hee-Joon | - |
dc.date.accessioned | 2023-03-14T07:40:18Z | - |
dc.date.available | 2023-03-14T07:40:18Z | - |
dc.date.created | 2023-03-13 | - |
dc.date.issued | 2023-03 | - |
dc.identifier.issn | 1551-7144 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/87099 | - |
dc.description.abstract | Background: Oxiracetam may have a modest effect on preventing cognitive decline. Exercise can also enhance cognitive function. This trial aims to investigate the effect of oxiracetam on post-stroke cognitive impairment and explore whether this effect is modified by exercise. Furthermore, the mechanisms that mediate this effect will be investigated through a neural network analysis.Methods: This is a multicenter, randomized, double-blind, placebo-controlled phase IV trial. Patients who com-plained of cognitive decline 3 months after stroke and had a high risk of cognitive decline were eligible. Patients were randomly assigned to receive either 800 mg of oxiracetam or placebo twice daily for 36 weeks. After randomization, a predetermined exercise protocol was provided to each participant, and the degree of physical activity was assessed using wrist actigraphy at 4, 12, 24, and 36 weeks. Resting-state functional MRI was ob-tained in baseline and 36-week follow-up. Co-primary endpoints are changes in the Mini-Mental State Exami-nation and Clinical Dementia Rating-Sum of Boxes. Secondary endpoints include changes in the NINDS-CSN VCIHS-Neuropsychology Protocol, Euro QoL, patient's global assessment, and functional network connectivity. If there is a significant difference in physical activity between the two groups, the interaction effect between physical activity and the treatment group will be examined. A total of 500 patients were enrolled from February 2018, and the last patient's final follow-up was completed in September 2022.Conclusion: This trial is meaningful not only to prove the efficacy of oxiracetam, but also evaluate whether ex-ercise can modify the effects of medication and how cognitive function can be restored. Trial registration http://cris.nih.go.kr (KCT0005137). | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.relation.isPartOf | CONTEMPORARY CLINICAL TRIALS | - |
dc.title | Efficacy and safety of oxiracetam in patients with vascular cognitive impairment: A multicenter, randomized, double-blinded, placebo-controlled, phase IV clinical trial | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000932542400001 | - |
dc.identifier.doi | 10.1016/j.cct.2023.107108 | - |
dc.identifier.bibliographicCitation | CONTEMPORARY CLINICAL TRIALS, v.126 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85147310874 | - |
dc.citation.title | CONTEMPORARY CLINICAL TRIALS | - |
dc.citation.volume | 126 | - |
dc.contributor.affiliatedAuthor | Lee, Yeong Bae | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Vascular cognitive impairment | - |
dc.subject.keywordAuthor | Stroke | - |
dc.subject.keywordAuthor | Oxiracetam | - |
dc.subject.keywordAuthor | Exercise | - |
dc.subject.keywordAuthor | Functional MRI | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordPlus | ISCHEMIC ATTACK | - |
dc.subject.keywordPlus | STROKE | - |
dc.subject.keywordPlus | DEMENTIA | - |
dc.subject.keywordPlus | EXERCISE | - |
dc.subject.keywordPlus | SECONDARY | - |
dc.subject.keywordPlus | NETWORKS | - |
dc.subject.keywordPlus | HEALTH | - |
dc.subject.keywordPlus | CORTEX | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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