Zhang Kan, Wang Junyang, Peng Guoping, Liu Ping, He Fangping, Zhu Zude, Luo Benyan
Department of Neurology, The First Affiliated Hospital of Medical School of Zhejiang University, No.79 Qingchun Road, Hangzhou, 310003, China.
Collaborative Innovation Center for Language Competence, School of Linguistics and Arts, Jiangsu Normal University, Xuzhou, 221116, China.
Trials. 2019 Jan 8;20(1):26. doi: 10.1186/s13063-018-3143-0.
Mild cognitive impairment (MCI) is a transition state between asymptomatic stage and dementia. Amnestic MCI (aMCI) patients who mainly present with memory deficits are highly likely to progress to Alzheimer's disease (AD). At present, no broadly effective drug therapy is available to prevent the progression from memory deficit to dementia. Cognitive control training, which has transfer effects on multiple cognitive capacities including memory function in healthy old adults, has not yet been applied to aMCI.
METHODS/DESIGN: In this single-center, randomized double-blind placebo-controlled study, 70 aMCI patients will be recruited and randomly assigned to the training and control groups. The intervention is an Internet-based cognitive control training program performed for 30 min daily, five days per week, for 12 consecutive weeks. Neuropsychological assessment and structural and functional magnetic resonance imaging (MRI) will be performed at baseline and outcome. Primary outcomes are changes of episodic memory retrieval function. Secondary outcome measures are neuroplasticity changes measured by functional and structural MRI.
In this study, an Internet-based cognitive control training program is adopted to investigate whether cognitive control training can enhance the retrieval of episodic memory in aMCI patients. The combination of multi-modal MRI and neuropsychological tests could have a good sensitivity in evaluating the effects of cognitive control training and could also uncover the underlying neural underpinning.
ClinicalTrials.gov, NCT03133052 . Registered on 21 April 2017.
轻度认知障碍(MCI)是无症状阶段和痴呆之间的过渡状态。主要表现为记忆缺陷的遗忘型MCI(aMCI)患者极有可能进展为阿尔茨海默病(AD)。目前,尚无广泛有效的药物疗法可预防从记忆缺陷进展为痴呆。认知控制训练对包括健康老年人记忆功能在内的多种认知能力具有迁移效应,但尚未应用于aMCI。
方法/设计:在这项单中心、随机双盲安慰剂对照研究中,将招募70例aMCI患者并随机分配至训练组和对照组。干预措施是基于互联网的认知控制训练项目,每天进行30分钟,每周五天,连续进行12周。将在基线和结局时进行神经心理学评估以及结构和功能磁共振成像(MRI)检查。主要结局是情景记忆检索功能的变化。次要结局指标是通过功能和结构MRI测量的神经可塑性变化。
在本研究中,采用基于互联网的认知控制训练项目来调查认知控制训练是否可以增强aMCI患者的情景记忆检索。多模态MRI与神经心理学测试相结合在评估认知控制训练的效果方面可能具有良好的敏感性,并且还可以揭示潜在的神经基础。
ClinicalTrials.gov,NCT03133052。于2017年4月21日注册。