scholarly journals 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

2019 ◽  
Author(s):  
Shengnan Yue ◽  
Ting He ◽  
Baiyang Li ◽  
Yanqin Qu ◽  
Hongmei Peng ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Sleep Quality ◽  
The Elderly ◽  
Fecal Microbiota ◽  
Serum Markers ◽  
Amnestic Mild Cognitive Impairment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo

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 a bigger risk of progressing to dementia. Current studies suggest 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 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 16SrDNA and metagenomics analyses, and serum markers. Methods/design This 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, then will be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18-month follow-up. The primary outcome is Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-cog11). Secondary outcome measures are mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), serum concentrations of immunological factors and inflammatory cytokines, 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 microbita, concentration of certain serum markers.

scholarly journals 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

2019 ◽  
Author(s):  
Shengnan Yue ◽  
Ting He ◽  
Baiyang Li ◽  
Yanqin Qu ◽  
Hongmei Peng ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Sleep Quality ◽  
The Elderly ◽  
Fecal Microbiota ◽  
Serum Markers ◽  
Amnestic Mild Cognitive Impairment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo

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 a bigger risk of progressing to dementia. Current studies suggest 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 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 16SrDNA and metagenomics analyses, and serum markers. Methods/design This 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, then will be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18-month follow-up. The primary outcome is Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-cog11). Secondary outcome measures are mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), serum concentrations of immunological factors and inflammatory cytokines, 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 microbita, concentration of certain serum markers.

scholarly journals 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

2019 ◽  
Author(s):  
Shengnan Yue ◽  
Ting He ◽  
Baiyang Li ◽  
Yanqin Qu ◽  
Hongmei Peng ◽  
...  
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Sleep Quality ◽  
The Elderly ◽  
Fecal Microbiota ◽  
Serum Markers ◽  
Amnestic Mild Cognitive Impairment ◽  
Double Blind ◽  
Double Blind Placebo

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 a bigger risk of progressing to dementia. Current studies suggest 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 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 16SrDNA and metagenomics analyses, and serum markers. Methods: This 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-matched group in a 1:1 ratio, then will be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18-month follow-up. The primary outcome is Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-cog11). Secondary outcome measures are mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), serum concentrations of immunological factors and inflammatory cytokines, 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 microbita, concentration of certain serum markers. Trial Registration: ClinicalTrials.gov, ID: NCT03601000. Registered on 26 July 2018. Keywords: Amnestic Mild cognitive impairment (aMCI), Sleep, Gut microbiome, Older adults

CHF5074 Reduces Biomarkers of Neuroinflammation in Patients with Mild Cognitive Impairment: A 12-Week, Double-Blind, Placebo- Controlled Study

2013 ◽  
Vol 10 (7) ◽  
pp. 742-753 ◽  
Author(s):  
Joel Ross ◽  
Sanjiv Sharma ◽  
Jaron Winston ◽  
Margarita Nunez ◽  
Gabriella Bottini ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Characteristics of Cognitive Deficit in Amnestic Mild Cognitive Impairment With Subthreshold Depression

2019 ◽  
Vol 32 (6) ◽  
pp. 344-353 ◽  
Author(s):  
Zhiyu Sun ◽  
Zhijiang Wang ◽  
Lujie Xu ◽  
Xiaozhen Lv ◽  
Quanzheng Li ◽  
...  
Keyword(s):  
Working Memory ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Language Processing ◽  
Working Memory Capacity ◽  
The Elderly ◽  
Amnestic Mild Cognitive Impairment ◽  
Cognitive Domain ◽  
Subthreshold Depression ◽  
Cognitive Assessments

It is widely recognized that depression may precipitate the incidence of dementia in the elderly individuals and individuals with amnestic mild cognitive impairment (aMCI) in particular. However, the association between subthreshold depression (SD) and cognitive deficits in patients with aMCI remains unclear. To address this, we collected demographic information and conducted a battery of neuropsychological cognitive assessments in 33 aMCI participants with SD (aMCI/SD+), 33 nondepressed aMCI participants (aMCI/SD−), and 53 normal controls (NC). Both aMCI groups showed significantly poorer performance in most cognitive domains relative to the NC group (ie, memory, language, processing speed, and executive function). Notably, the aMCI/SD+ group showed significantly poorer attention/working memory compared with the aMCI/SD− group. Multiple linear regression analyses revealed a significant negative association between the severity of depressive symptoms and attention/working memory capacity (β = − .024, P = .024), accounting for 8.28% of the variations in this cognitive domain. All statistical analyses were adjusted by age, sex, and years of education. A logistic regression model had an accuracy of 72.4% in discriminating between the aMCI/SD+ and aMCI/SD− groups based on individual cognitive profiles over 6 domains. Our findings indicate that patients with aMCI with and without SD have distinct patterns of cognitive impairment. This finding may facilitate the diagnosis and treatment of SD in patients with aMCI.

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