Clinical trial NCT03601000: Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment
Official title: Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cognitive Dysfunction
Keywords: amnestic
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled study.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject has assigned informed consent to participate in the study and continues to give willing consent for participation
* Age from 60 to 85 years with a diagnosis of aMCI
* Educational level of at least 6 years
* Availability of a "study partner" who can assist in completing rating scales for the duration of the study
* Cognitive complaints reported by the subject and confirmed by the "study partner"
* Clinical Dementia Rating (CDR) global score of 0.5, and memory item score of 0.5
* Mini-mental state examination (MMSE) score of 24-30
* Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-V) criteria of dementia not fulfilled

Exclusion Criteria:

* Has been previously enrolled in this study and received the investigational product
* Has received an investigational product within 30 days prior to screening
* Has received disease-modifying therapy
* Has a known allergy to the study drug or any of its constituents
* Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study entry, or is an alcoholic or drug addict, as determined by the investigator
* Has ongoing clinically significant (as judged by the investigator), metabolic or any other disease that could currently cause impaired memory (e.g., untreated thyroid disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)
* Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
* Has a parkinsonian movement disorder
* Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (e.g., benzodiazepines, sedatives, antipsychotics)
* History of major recurrent depressive disorder (DSM-V) within the last 5 years prior to screening
* Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history of head trauma or brain surgery
* Has signs of major cerebrovascular disease, with score of modified Hachinski Ischemia Score (mHIS) at more than 4, or as verified by medical history and/or brain MRI or CT
* Has severe visual or hearing impairments that cannot cooperate with examinations
* Has severe digestive system diseases
* Has received antibiotics within 60 days prior to screening

Primary outcomes:
measure: Change from Baseline in Alzheimer´s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score
timeFrame: Baseline, 16 weeks, 22 months
Secondary outcomes:
measure: Change from Baseline in the Mini Mental Status Examination (MMSE)
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
measure: Change from Baseline in the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
measure: Change from Baseline in the Clinical Dementia Rating Scale (CDR)
timeFrame: Baseline, 16 weeks, 22 months
measure: Change from Baseline in the Activity of Daily Living (ADL)
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
measure: Change from Baseline in the Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months
measure: Differences between patients with aMCI and individuals with normal cognition in gut microbiome.
timeFrame: Baseline, 16 Weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Leshan
country: China
facility: Welfare Institution of Emei Civil Administration
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Wenbin Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miao YC, Tian JZ, Shi J, Mao M. Effects of Chinese medicine for tonifying the kidney and resolving phlegm and blood stasis in treating patients with amnestic mild cognitive impairment: a randomized, double-blind and parallel-controlled trial. Zhong Xi Yi Jie He Xue Bao. 2012 Apr;10(4):390-7. doi: 10.3736/jcim20120407.
citation: Yue S, He T, Li B, Qu Y, Peng H, Chen J, Lei M, Chen C, Wu W. 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. Trials. 2019 Aug 20;20(1):518. doi: 10.1186/s13063-019-3607-x.