Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology

Yiqi Lin, Binyin Li, Huidong Tang, Qun Xu, Yuncheng Wu, Qi Cheng, Chunbo Li, Shifu Xiao, Lu Shen, Weiguo Tang, Hui Yu, Naying He, Huawei Lin, Fuhua Yan, Wenwei Cao, Shilin Yang, Ye Liu, Wei Zhao, Dong Lu, Bin Jiao, Xuewen Xiao, Lin Zhou, Shengdi Chen, Yiqi Lin, Binyin Li, Huidong Tang, Qun Xu, Yuncheng Wu, Qi Cheng, Chunbo Li, Shifu Xiao, Lu Shen, Weiguo Tang, Hui Yu, Naying He, Huawei Lin, Fuhua Yan, Wenwei Cao, Shilin Yang, Ye Liu, Wei Zhao, Dong Lu, Bin Jiao, Xuewen Xiao, Lin Zhou, Shengdi Chen

Abstract

Background: Mild cognitive impairment is an early stage of Alzheimer's disease. Increasing evidence has indicated that cognitive training could improve cognitive abilities of MCI patients in multiple cognitive domains, making it a promising therapeutic approach for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent how it could reduce the convertion rate from MCI to AD.

Methods/design: The SIMPLE study is a multicenter, randomized, single-blind prospective clinical trial assessing the effects of computerized cognitive training on different cognitive domains in MCI patients. It is carried out in 7 centers in China. The study population includes patients aged 50-85, and they are randomly allocated to the training or control group. The primary outcome is to compare the conversion rate of MCI within 36-month follow-up. Structural and functional MRI will be used to interpret the effect of cognitive training. The cognitive training comprises a variety of games related with cognitive domains such as attention, memory, visualspatial ability and executive function. We cautiously set 50% reduction in the rate of conversion as estimated effect. With 80-90% statistical power and 12% as the overall probability of conversion within the study period, 600-800 patients are finally required in the study. The first patent has been recruited in April 2017.

Discussion: Previous studies suggested the benefit of cognitive training for MCI, but neither long-time nor Chinese culture were investigated. The SIMPLE designs and utilizes an improved computerized cognitive training approach and assesses its effects on MCI progress. In addition, neural activities explaining the effects on cognition function changes will be revealed, which could in turn to imply more useful therapeutic approaches.

Trial registration: ClinicalTrials.gov Identifier: NCT03119051.

Keywords: China; Cognitive training; Longitude evaluation; Mild cognitive impairment; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

Conformed to the ethical principles proclaimed in the Declaration of Helsinki in 1964, and revised in Tokyo in 2004, the study protocol has been reviewed and thus approved by independent ethics committees in the Ruijin Hospital, which is the leading center of the study. Before the inclusion, written informed consent forms will be signed by patients or their surrogate family member after a detailed explanation. The SIMPLE study is registered with Chinese Trial Registry.gov and ClinicalTrial.gov (Register number: ChiCTR-INR-16008959 and NCT03119051).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The SIMPLE study flowchart. The flowchart included the general protocol of recruitment, grouping, follow-up and final analysis

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