Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment

Background and Aim: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were –2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

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Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial

Journal of Alzheimer s Disease ◽

10.3233/jad-200488 ◽

2020 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Jinzhong Xiao ◽

Noriko Katsumata ◽

Francois Bernier ◽

Kazuya Ohno ◽

Yuki Yamauchi ◽

...

Keyword(s):

Older Adults ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Cognitive Functions ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Bifidobacterium Breve

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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

10.21203/rs.2.249/v1 ◽

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

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