Yu Congcong, Yang Huijie, Zhang Bing, Chen Shihua, Yang Sijue, Li Fangyi, Zhu Wenhui, Zhai Beibei, Wu Tianyu, Zhao Shengyi, Zhang Wen, Tong Xuewei, Duan Yanjie, Zhang Lu, Chao Yining, Wu Jindan, Zhu Xiaowei, Wang Kun, Ye Xinhua, Zhang Xiaoya, Xu Xiang, Cheng Haiyan, Liu Jie, Zhang Jie, Wang Ying, Zhang Zhou, Yan Weili, Bi Yan
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China.
Branch of National Clinical Research Centre for Metabolic Diseases, Nanjing, Jiangsu, China.
BMJ Open. 2025 Aug 21;15(8):e095382. doi: 10.1136/bmjopen-2024-095382.
Diabetes is a significant modifiable risk factor for cognitive dysfunction. There are currently no effective treatments that delay or reverse the progression of cognitive dysfunction. Accumulating evidence demonstrates that specific antidiabetes medications hold promise in improving cognitive function. However, the comparative effects of various antidiabetic drug classes on cognitive protection remain to be fully elucidated. This study aims to investigate and compare the cognitive benefits of liraglutide, empagliflozin and linagliptin on achieving mild cognitive impairment (MCI) remission in individuals with type 2 diabetes (T2D).
The LIGHT-MCI trial is an investigator-initiated, multicentre, open-label, parallel-group, randomised, superiority trial involving T2D patients with MCI, consisting of a 48-week core study followed by an extension phase through to 76 weeks. A total of 396 participants will be randomly allocated 1:1:1 to receive liraglutide, empagliflozin or linagliptin treatment. The primary outcome measure is the efficacy difference of liraglutide, empagliflozin and linagliptin in achieving MCI remission in individuals with T2D. The key secondary outcome measures include changes in scores of general cognition and various cognitive subdomains (including processing speed, executive function, immediate memory, visuospatial construction ability, language, attention and delayed memory), basic and instrumental daily living ability, MRI-derived normalised measures of total brain volume, cerebral microstructures, cortical and nuclear volume, white matter hyperintensity, volume, white matter microstructural integrity, odour-induced brain activation and resting-state functional connectivity, olfactory function and metabolic parameters.
The LIGHT-MCI trial has received approval from the Ethics Committees of the Drum Tower Hospital Affiliated to Nanjing University Medical School (2022-092-02) and other participating centres in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation for Good Clinical Practice (ICH GCP E6). Informed consent is required for participation. Findings from this trial are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.
NCT05313529.
糖尿病是认知功能障碍的一个重要可改变风险因素。目前尚无有效治疗方法可延缓或逆转认知功能障碍的进展。越来越多的证据表明，特定的抗糖尿病药物有望改善认知功能。然而，各类抗糖尿病药物对认知保护的比较效果仍有待充分阐明。本研究旨在调查和比较利拉鲁肽、恩格列净和利奈格列汀对2型糖尿病（T2D）患者实现轻度认知障碍（MCI）缓解的认知益处。
LIGHT-MCI试验是一项由研究者发起的、多中心、开放标签、平行组、随机、优效性试验，涉及患有MCI的T2D患者，包括一项为期48周的核心研究，随后是一个延长阶段，直至76周。总共396名参与者将按1:1:1随机分配，接受利拉鲁肽、恩格列净或利奈格列汀治疗。主要结局指标是利拉鲁肽、恩格列净和利奈格列汀在T2D患者中实现MCI缓解的疗效差异。关键次要结局指标包括一般认知和各种认知子领域（包括处理速度、执行功能、即时记忆、视觉空间构建能力、语言、注意力和延迟记忆）得分的变化、基本和工具性日常生活能力、MRI衍生的全脑体积、脑微结构、皮质和核体积、白质高信号、体积、白质微结构完整性、气味诱发的脑激活和静息态功能连接、嗅觉功能和代谢参数的标准化测量。
LIGHT-MCI试验已获得南京大学医学院附属鼓楼医院伦理委员会（2022-092-02）及其他参与中心根据《赫尔辛基宣言》和国际协调会议关于良好临床实践（ICH GCP E6）的原则批准。参与需要获得知情同意。本试验的结果将通过同行评审出版物、会议报告、通讯和社交媒体进行传播。
NCT05313529。
