Clinical observation and mechanism of acupuncture on amnestic mild cognitive impairment based on the gut-brain axis: study protocol for a randomized controlled trial

Abstract

BackgroundAmnestic mild cognitive impairment (aMCI) is a pre-dementia condition associated with declined cognitive function dominated by memory impairment. The occurrence of aMCI is associated with the gut-brain axis. Previous studies have shown cognitive improvements in MCI after acupuncture treatment. This study evaluates whether acupuncture can produce a therapeutic effect in patients with aMCI by modulating the gut-brain axis.Methods and designThis is a prospective, parallel, multicenter randomized controlled trial. A total of 40 patients with aMCI will be randomly assigned to an acupuncture group (AG) or a waiting-list group (WG), participants in both groups will receive health education on improving cognitive function at each visit, and acupuncture will be conducted twice a week for 12 weeks in the AG. Another 20 matched healthy volunteers will be enrolled as normal control. The primary outcome will be the change in Alzheimer’s Disease Assessment Scale-cognitive scale score before and after treatment. Additionally, functional magnetic resonance imaging data, faeces, and blood will be collected from each participant to characterize the brain function, gut microbiota, and inflammatory cytokines, respectively. The differences between patients with aMCI and healthy participants, and the changes in the AG and WG groups before and after treatment will be observed. Ultimately, the correlation among brain function, gut microbiota, inflammatory cytokines, and clinical efficacy evaluation in patients with aMCI will be analyzed.DiscussionThis study will identify the efficacy and provide preliminary data on the possible mechanism of acupuncture in treating aMCI. Furthermore, it will also identify biomarkers of the gut microbiota, inflammatory cytokines, and brain function correlated with therapeutic effects. The results of this study will be published in peer-reviewed journals.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2200062084.

Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study

“…Moreover, body acupuncture will not be adopted. MCI is a neurodegenerative (12,13,15,(32)(33)(34). Sham acupuncture has been used in clinical studies on acupuncture to exclude the placebo effects.…”

“…that progresses slowly; therefore, the treatment duration was changed from 8 weeks to 12 weeks to achieve sufficient therapeutic effects based on the findings of previous studies(21,(32)(33)(34). Third, the interventions of the test and control groups were changed from EA combined with CCR and CCR to EA and CCR, respectively, to explore the effects of EA on MCI rather than add-on effects.…”