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.
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.
['Yue|Shengnan|S|', 'He|Ting|T|', 'Li|Baiyang|B|', 'Qu|Yanqin|Y|', 'Peng|Hongmei|H|', 'Chen|Jinxin|J|', 'Lei|Ming|M|', 'Chen|Chongli|C|', 'Wu|Wenbin|W|http://orcid.org/0000-0001-8784-6137']
D000368:Aged D000369:Aged, 80 and over D000647:Amnesia D015415:Biomarkers D002681:China D003071:Cognition D060825:Cognitive Dysfunction D004311:Double-Blind Method D004365:Drugs, Chinese Herbal D005260:Female D000069196:Gastrointestinal Microbiome D006801:Humans D006993:Hypnotics and Sedatives D018836:Inflammation Mediators D008297:Male D008568:Memory D008875:Middle Aged D018697:Nootropic Agents D016032:Randomized Controlled Trials as Topic D012890:Sleep D013997:Time Factors D016896:Treatment Outcome
Sleep Older adults Amnestic mild cognitive impairment Gut microbiome