Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study)
Introduction The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer’s disease re...
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BMJ Publishing Group
2024-07-01
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| author | Pin Wang Chang Xu Yufei Chen Yuting Yang Jin Gong Wenxian Sun Xiaodong Han Heya Luan Shaoqi Li Ruina Li Boye Wen Sirong Lv Cuibai Wei |
| author_facet | Pin Wang Chang Xu Yufei Chen Yuting Yang Jin Gong Wenxian Sun Xiaodong Han Heya Luan Shaoqi Li Ruina Li Boye Wen Sirong Lv Cuibai Wei |
| author_sort | Pin Wang |
| collection | DOAJ |
| description | Introduction The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer’s disease remains uncertain. This study aims to evaluate the efficacy and safety of NBP in improving cognitive function in patients with mild cognitive impairment (MCI) through a clinical randomised controlled trail.Methods and analysis This study is a 12-month, randomised, double-blind, placebo-controlled, multicentric trial, involving 270 patients with MCI. Subjects are randomly assigned to receive either NBP soft capsule (200 mg, three times per day) or placebo with an allocation ratio of 1:1. The efficacy and safety of NBP are assessed by comparing the results of neuropsychological, neuroimaging and laboratory tests between the two groups. The primary endpoint is the change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale after 12 months. All patients will be monitored for adverse events.Ethics and dissemination This study involving human participants has been reviewed and approved by Ethics Committee of Xuan Wu Hospital (No.2017058). The participants provide their written informed consent to participate in this study. Results will be published in peer-reviewed medical journals and disseminated to healthcare professionals at local and international conferences.Protocol version V 3.0, 3 September 2022.Trial registration number ChiCTR1800018362. |
| format | Article |
| id | doaj-art-4258eb00a6334e37950a94c2d498175f |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
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| spelling | doaj-art-4258eb00a6334e37950a94c2d498175f2025-08-20T02:13:11ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2023-082404Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study)Pin Wang0Chang Xu1Yufei Chen2Yuting Yang3Jin Gong4Wenxian Sun5Xiaodong Han6Heya Luan7Shaoqi Li8Ruina Li9Boye Wen10Sirong Lv11Cuibai Wei121 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, ChinaDepartment of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, People`s Republic of China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, ChinaDepartment of Nursing, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China2 College of Integrated Traditional Chinese and Western Medicine, Changchun University of Chinese Medicine, Changchun, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China2 College of Integrated Traditional Chinese and Western Medicine, Changchun University of Chinese Medicine, Changchun, China3 School of Biological Science and Medical Engineering, Beihang University, Beijing, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China1 Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, ChinaIntroduction The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer’s disease remains uncertain. This study aims to evaluate the efficacy and safety of NBP in improving cognitive function in patients with mild cognitive impairment (MCI) through a clinical randomised controlled trail.Methods and analysis This study is a 12-month, randomised, double-blind, placebo-controlled, multicentric trial, involving 270 patients with MCI. Subjects are randomly assigned to receive either NBP soft capsule (200 mg, three times per day) or placebo with an allocation ratio of 1:1. The efficacy and safety of NBP are assessed by comparing the results of neuropsychological, neuroimaging and laboratory tests between the two groups. The primary endpoint is the change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale after 12 months. All patients will be monitored for adverse events.Ethics and dissemination This study involving human participants has been reviewed and approved by Ethics Committee of Xuan Wu Hospital (No.2017058). The participants provide their written informed consent to participate in this study. Results will be published in peer-reviewed medical journals and disseminated to healthcare professionals at local and international conferences.Protocol version V 3.0, 3 September 2022.Trial registration number ChiCTR1800018362.https://bmjopen.bmj.com/content/14/7/e082404.full |
| spellingShingle | Pin Wang Chang Xu Yufei Chen Yuting Yang Jin Gong Wenxian Sun Xiaodong Han Heya Luan Shaoqi Li Ruina Li Boye Wen Sirong Lv Cuibai Wei Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) BMJ Open |
| title | Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) |
| title_full | Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) |
| title_fullStr | Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) |
| title_full_unstemmed | Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) |
| title_short | Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study) |
| title_sort | efficacy and safety of butylphthalide in patients with mild cognitive impairment a multicentre randomised double blind placebo controlled trial ebmci study |
| url | https://bmjopen.bmj.com/content/14/7/e082404.full |
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