The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial.
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.
['Xing|Yi|Y|', 'Zhu|Zude|Z|', 'Du|Yifeng|Y|', 'Zhang|Junjian|J|', 'Qu|Qiumin|Q|', 'Sun|Li|L|', 'Li|Yang|Y|', 'Guo|Yanjun|Y|', 'Peng|Guoping|G|', 'Liu|Yong|Y|', 'Yu|Yueyi|Y|', 'Qiao|Yuchen|Y|', 'Xie|Beijia|B|', 'Shi|Xinrui|X|', 'Lu|Jie|J|', 'Jia|Jianping|J|', 'Tang|Yi|Y|']
D000647:Amnesia D015928:Cognitive Behavioral Therapy D060825:Cognitive Dysfunction D006801:Humans D009483:Neuropsychological Tests D012107:Research Design D016896:Treatment Outcome
ClinicalTrials.gov NCT04063956