Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment

Chengdu University of Traditional Chinese Medicine

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cognitive Dysfunction

Treatments

Drug: Placebo

Drug: Yi-Zhi-An-Shen

Study type

Interventional

Funder types

Other

Identifiers

NCT03601000

ChengduUTCM-WWB-201801

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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