The main purpose of this study is to investigate the safety and efficacy of Yi-Zhi-An-Shen Granules in participants with amnestic mild cognitive impairment (aMCI).
The investigators performed a randomized, placebo-controlled, double-blind study on evaluating effect of Yi-Zhi-An-Shen Granules on cognition, sleep quality, and gut microbiome of older adults with amnestic mild cognitive impairment (aMCI). The investigators plan to involve 80 cases for observation in 2 years (40 cases for each group), expecting that cognition and sleep quality of aMCI patients can be improved by Yi-Zhi-An-Shen Granules versus placebo, and discussing the differences between individuals with aMCI and ones with normal cognition, also investigating whether this Chinese medicine compound can regulate gut microbiome of older individuals with aMCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.
Placebo granules 5g given three times a day for up to 16 weeks.
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Welfare Institution of Emei Civil Administration
Leshan, Sichuan, China
Change from Baseline in Alzheimer´s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score
The ADAS-Cog was developed as an outcome measure for global cognition in clinical trials. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation, for a total of 70 points (0: no cognitive impairment; 70: severe impairment). An improvement of 4 points is used as a criterion of clinically effective anti-dementia drugs.
Time frame: Baseline, 16 weeks, 22 months
Change from Baseline in the Mini Mental Status Examination (MMSE)
Changes in the global cognitive function will be accessed by MMSE to evaluate the severity of subjects' cognitive impairment. The MMSE includes orientation, registration, attention and calculation, recalling and language tests, for a total of 30 points. A score below 24 is considered abnormal for dementia screening.
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
Change from Baseline in the Montreal Cognitive Assessment (MoCA)
MoCA (Changsha Version), as a assessment tool for rapid MCI screening, will be used to assess changes in the global cognitive function. With a total of 30 points, a score below 25 is considered abnormal, and the lower score indicates the worse cognition.
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
Change from Baseline in the Clinical Dementia Rating Scale (CDR)
The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD and related dementias: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. Scores on the CDR range from 0 (no impairment) to 3 (severe impairment). The total CDR ratings for each of the six cognitive/functional domains can be added to create a CDR sum of boxes (CDR-SB).
Time frame: Baseline, 16 weeks, 22 months
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Change from Baseline in the Activity of Daily Living (ADL)
ADLs will be assessed including basic activities of daily living (BADL) and instrumental activities of daily living (IADL). An individual's BADL will be evaluated mainly by the subjects' performance from the perspectives of bathing, dressing, grooming, initiation, toileting and feeding, with six items and a sum of scores ranging from 0 (normal) to 24 (complete dependence on others). And modified Lawton Instrumental Activities of Daily Living Scale will be used to measure the IADL of a subject, with eight items and a sum of scores ranging from 0 (normal) to 32 (complete dependence on others).
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
Change from Baseline in the Pittsburgh sleep quality index (PSQI)
The PSQI will be used to assess participants' comprehensive sleep quality, including sleep quality, sleep duration, sleep efficiency, sleep disorders, daytime dysfunction, sleeping aids, etc. The total score is 21, with a higher score indicating a worse sleep quality.
Time frame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
Differences between patients with aMCI and individuals with normal cognition in gut microbiome.
The investigators will collect some fecal samples from participants. Then, differences in gut microbiome between patients with aMCI and individuals with normal cognition will be analyzed using 16SrDNA and Metagenomics analyses. When it is available, the investigators will also assess the change in gut microbiome between the treatment group and the placebo group after the intervention of YZASG.
Time frame: Baseline, 16 Weeks