Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial

Abstract

Background Amnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to dementia. Current studies suggest that good sleep quality is linked with preserved cognition in the elderly, and sleep complaints are common among the elderly with amnesia. Therefore, improving their sleep may be helpful for maintaining and improving their cognitive capacity. According to the theory of traditional Chinese medicine, Yi-Zhi-An-Shen is an herbal compound which may ameliorate forgetfulness and sleep disorders. As growing evidence indicates that the gut microbiome is associated with major mental symptoms, a hypothesis was proposed that Yi-Zhi-An-Shen granules (YZASG) might work by alternating microbial abundance and diversity. In this study, the investigators intend to assess the efficacy of YZASG on global cognition in the elderly suffering from aMCI and evaluate its safety as well as its potential mechanisms via sleep quality, fecal microbial 16S ribosomal DNA and metagenomics analyses, and serum markers. Methods/design This study is a randomized, double-blind, placebo-controlled clinical trial. A total of 80 patients (aged 60–85 years) will be recruited and allocated randomly to a treatment group and a placebo group in a 1:1 ratio and will then be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18 months follow-up. The primary outcome is the Alzheimer’s Disease Assessment Scale-Cognitive Subscale. Secondary outcome measures are the Mini-Mental State Examination, Montreal Cognitive Assessment, Pittsburgh Sleep Quality Index, serum concentrations of immunological factors and inflammatory cytokines, and fecal microbiota. Fecal microbiota will only be collected at the baseline and endpoint of the intervention. Discussion The results of this trial will be conducive to assessing the safety and effectiveness on cognition of YZASG in intervening aMCI among the elderly and determining if it takes effect via the improvement of sleep quality, regulation of gut microbiota, and concentration of certain serum markers. Trial registration ClinicalTrials.gov, NCT03601000 . Registered on 26 July 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3607-x) contains supplementary material, which is available to authorized users.

Inhibition of Rho Kinase by Fasudil Ameliorates Cognition Impairment in APP/PS1 Transgenic Mice via Modulation of Gut Microbiota and Metabolites

“…It has also been demonstrated to modulate the physiological aspects of neurodegenerative disorders (Fujii et al, 2019 ). A plethora of evidence suggests that the role of gut microbiota and its metabolites in pathogenesis and progression of AD (Minter et al, 2017 ; Yue et al, 2019 ; Marizzoni et al, 2020 ).…”

B serum proteome profiles revealed dysregulated proteins and mechanisms associated with insomnia patients: A preliminary study

“…The pharmacotherapy of insomnia has been changing over the past few decades, and traditional Chinese medicine (TCM) has been widely used for the treatment of insomnia due to its advantages, such as high efficacy, no drug resistance, and low toxicity ( Singh and Zhao, 2017 ; Yue et al, 2019 ). For drug prediction of key DEPs, FN1, EGF, HP, and IGF1 were found to be potentially target-regulated by natural compounds.…”

Research trend of microbiota-gut-brain axis in Alzheimer’s disease based on CiteSpace (2012–2021): A bibliometrics analysis of 608 articles

“…For instance, Liuwei Dihuang decoction, baicalein, Yi-Zhi-An-Shen granules, Jatrorrhizine, etc. ( Wang et al, 2016 ; Gao et al, 2018 ; Wang J. H. et al, 2019 ; Wang S. et al, 2019 ; Yue et al, 2019 ).…”