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

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.Electronic supplementary materialThe online version of this article (10.1186/s12883-018-1100-x) contains supplementary material, which is available to authorized users.

The comparative effectiveness of traditional Chinese medicine exercise therapies in elderly people with mild cognitive impairment

“…Early intervention can effectively delay or even prevent the progression of MCI to dementia. [ 7 , 8 ] At present, MCI's drug interventions mainly include symptomatic treatments (such as cholinesterase inhibitors, N-methyl-D-aspartic acid receptor, ergot alkaloid preparations, etc) and etiological treatments (such as antidiabetic drugs, antihypertensive drugs, etc). [ 9 , 10 ] However, certain side effects and adverse reactions do exist in drug interventions, so the current clinical treatments are still based on non-drug interventions.…”

Correlates of Mild Cognitive Impairment of Community-Dwelling Older Adults in Wuhan, China

“…The total estimated worldwide cost of dementia will rise to two trillion U.S. dollars by 2030 [1]. Mild cognitive impairment (MCI) is considered as an early stage of Alzheimer’s disease or other forms of dementia that mainly occurs in older adults [2,3,4,5]. It does not usually interfere with an individual’s daily life, but there is a higher risk of this condition progressing to dementia compared with age-matched controls [5].…”

“…It does not usually interfere with an individual’s daily life, but there is a higher risk of this condition progressing to dementia compared with age-matched controls [5]. In spite of this, there is still an opportunity to prevent the progression to dementia [3,4]. MCI may occur as a transitional stage between normal aging and dementia, and some effective interventions may reduce the conversion rate [3,4,5].…”

“…In spite of this, there is still an opportunity to prevent the progression to dementia [3,4]. MCI may occur as a transitional stage between normal aging and dementia, and some effective interventions may reduce the conversion rate [3,4,5]. The American Academy of Neurology’s clinical practice guideline on MCI concluded that 14.4–55.6% of people diagnosed with MCI may return to being neurologically intact [5].…”

“…MCI is a major public health problem in low- and middle-income countries like China since it is common in older populations, and its prevalence increases with age [1,3,4]. However, this important issue has not yet received sufficient attention from the Chinese society and has not been studied seriously in China, and to date, there is little scientific literature focusing on this topic [6,7].…”