The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial

Article type: Research Article

Authors: Xing, Yi^{a; b} | Zhu, Zude^c | Du, Yifeng^d | Zhang, Junjian^e | Qu, Qiumin^f | Sun, Li^g | Li, Yang^h | Guo, Yanjunⁱ | Peng, Guoping^j | Liu, Yong^k | Yu, Yueyi^{a; b} | Qiao, Yuchen^{a; b} | Xie, Beijia^{a; b} | Shi, Xinrui^{a; b} | Lu, Jie^l | Jia, Jianping^{a; b} | Tang, Yi^{a; b; *}

Affiliations: [a] Innovation Center for Neurological Disorders, Department of Neurology, Xuanwu Hospital, Capital Medical University, National Clinical Research Center for Geriatric Disorders, Beijing, China | [b] Key Laboratory of Neurodegenerative Diseases, Ministry of Education of the People’s Republic of China, Beijing, China | [c] Collaborative Innovation Center for Language Ability, Jiangsu Normal University, Xuzhou, China | [d] Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China | [e] Department of Neurology, Zhongnan Hospital, Wuhan University, Wuhan, China | [f] Department of Neurology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China | [g] Department of Neurology and Neuroscience Center, The First Hospital of Jilin University, Changchun, China | [h] Department of Neurology, First Hospital of Shanxi Medical University, Taiyuan, China | [i] Department of Neurology, Beijing Friendship Hospital, Beijing, China | [j] Department of Neurology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China | [k] Brainnetome Center, Institute of Automation, Chinese Academy of Sciences, Beijing, China | [l] Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing, China

Correspondence: [*] Correspondence to: Yi Tang, Innovation Center for Neurological Disorders & Department of Neurology, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Beijing 100053, China. Tel.: +86 10 83199456; E-mail: [email protected].

Abstract: Background:Amnestic mild cognitive impairment (aMCI) is often the prodromal stage of Alzheimer’s disease (AD). Although previous studies have suggested that computerized cognitive training is an effective non-pharmacological intervention for aMCI, large-sample, randomized controlled studies are warranted to provide a high level of evidence. Objective:To identify the efficacy of computerized cognitive training for aMCI. Methods:This study will include 260 patients diagnosed with aMCI from 8 centers in China. A computerized multi-domain adaptive training program will be used in this study, and the targeted cognitive domains include memory, attention, language, and executive function. The patients will be randomized into either a cognitive-training group or an active-control group. The intervention is a 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week. Neuropsychological assessments and structural and functional MRI will be obtained at baseline, at the end of the intervention, and 6 months after randomization. The primary outcome will be the global cognitive function score assessed by Montreal Cognitive Assessment. The secondary outcomes include changes in other neuropsychological assessments and neuroplasticity changes measured by structural and functional MRI. Results:The trial is currently ongoing, and it is anticipated that recruitment will be completed in December 2020. Conclusion:This multi-center, large-sample, randomized controlled trial will investigate the short and long-term effects of computerized cognitive training in patients with aMCI. Furthermore, the combination of functional and structural MRI results will also reveal the underlying mechanisms of the effect of intervention.

Keywords: ClinicalTrials.gov NCT04063956

Keywords: Cognitive training, mild cognitive impairment, non-pharmacological intervention, randomized controlled clinical trial

DOI: 10.3233/JAD-191314

Journal: Journal of Alzheimer's Disease, vol. 75, no. 3, pp. 779-787, 2020