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

NCT03601000 | Completed Phase 1 DMC

• 1 other identifier: ChengduUTCM-WWB-201801
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Cognitive Dysfunction

Keywords

amnestic

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 16 weeks, 22 months

Secondary Outcomes (6)

• Change from Baseline in the Mini Mental Status Examination (MMSE)

  Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

• Change from Baseline in the Montreal Cognitive Assessment (MoCA)

  Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

• Change from Baseline in the Clinical Dementia Rating Scale (CDR)

  Baseline, 16 weeks, 22 months

• Change from Baseline in the Activity of Daily Living (ADL)

  Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

• Change from Baseline in the Pittsburgh sleep quality index (PSQI)

  Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

Study Arms (2)

Yi-Zhi-An-Shen

EXPERIMENTAL

Yi-Zhi-An-Shen Granules given three times every day for 16 weeks.

Drug: Yi-Zhi-An-Shen

Placebo

PLACEBO COMPARATOR

Placebo given three times every day for 16 weeks.

Drug: Placebo

Interventions

Yi-Zhi-An-Shen DRUG

Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.

Yi-Zhi-An-Shen

Placebo DRUG

Placebo granules 5g given three times a day for up to 16 weeks.

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (2)

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Welfare Institution of Emei Civil Administration

Leshan, Sichuan, China

Location

Related Publications (2)

• 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.

  PMID: 22500712 BACKGROUND

• 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.

  PMID: 31429790 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

yi-zhi-an-shen

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wenbin Wu

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled study.

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: July 26, 2018
• Study Start: April 21, 2018
• Primary Completion: April 30, 2019
• Study Completion: September 12, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (2)