Abstract

BackgroundMild 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/designThe 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.DiscussionPrevious 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 registrationClinicalTrials.gov Identifier: NCT03119051.

Highlights

  • Mild cognitive impairment is an early stage of Alzheimer’s disease

  • Previous studies suggested the benefit of cognitive training for mild cognitive impairment due to AD (MCI), but neither long-time nor Chinese culture were investigated

  • Neural activities explaining the effects on cognition function changes will be revealed, which could in turn to imply more useful therapeutic approaches

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Summary

Introduction

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. The disease seriously impaired cognitive functions and daily living abilities, posing heavy care and economic burden on patients’ families and the society. The American Cognitive Function and Aging Study (ACFAS) indicates that the prevalence of AD among people over 65 is 6.5% [1]. In Shanghai, one of the most biggest cities in China, the prevalence of cognition impairment in people over 60 in rural regions and over 55 in urban areas are reported to be 7 and 8.38% respectively [2, 3]. The number of AD patients in China is estimated to reach 23.3 million in 2030 [4]

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