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Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
smart soup
Donepezil
Memantine
Placebo
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, Traditional Chinese Medicine, Smart soup

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • NIA-AA 2011 AD probable Alzheimer's disease, mild to moderate, stable use donepezil 10mg/d for 3 months
  • NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months
  • NIA-AA 2011 MCI probable criteria
  • stable care giver
  • Traditional Chinese medicine diagnosis: pixu tanzhuo

Exclusion Criteria:

  • Severe systemic disease (heart, liver ,kidney function failure)
  • contradictions of MRI examination

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Group I severe AD

Group II severe AD

Group III Mild or moderate AD

Group IV Mild or moderate AD

Group V MCI

Group VI MCI

Arm Description

Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and smart soup

Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and placebo

Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and smart soup

Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and placebo

Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup

Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo

Outcomes

Primary Outcome Measures

Changes of cognitive screening
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Changes of comprehensive cognitive assessment
Use the neuropsychological scales, Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog 0-75), to assess every three months after trial entry
Changes in the degree of dementia
Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Changes in behavior
Use the Cohen-Mansfield Agitation Inventory (CMAI,29-203) to assess every three months after trial entry
Changes in Psychiatric symptoms
Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Changes of daily living skills
Use Activity of Daily Living Scale(ADL,20-80)to assess every three months after trial entry
Changes in health status
Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Tau and Beta-amyloid biomarkers in CSF and plasma
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) and plasma of patients with dementia and controls
Magnetic resonance imaging and Electroencephalogram(EEG)
Evaluate the imaging and EEG changes of dementia patients. Specifically, EEG can be used to monitor the activity of brain waves in different parts of the cerebral cortex (e.g. power in alpha band, distribution and power of slow theta/delta waves etc.)
Oxidative stress markers in blood
Concentration of Dopamine in blood of patients with dementia and controls
Alterations of neurotransmitters in the blood
Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls

Secondary Outcome Measures

Full Information

First Posted
April 12, 2022
Last Updated
September 10, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
Tongji University
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1. Study Identification

Unique Protocol Identification Number
NCT05538507
Brief Title
Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
Official Title
Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Tongji University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a prospective interventional randomized controlled single center trial. The goal of the trial is to evaluate the efficacy of smart soup on cognition, behavior, biomarkers and safety in Alzheimer's disease (aMCI and dementia).
Detailed Description
Alzheimer's disease (AD) is the most common cause of dementia and places a heavy burden on patients, families, society and healthcare. The drugs that have been marketed worldwide for the treatment of AD so far can only delay but not reverse the course of the disease, and the current drug development is all directed at a single target, while the onset of AD is the result of a combination of multiple factors, which is an important reason why so many drugs have faltered. The investigators need to find new multi-target intervention pathways from another perspective. The advantage of Chinese medicine is multi-target and multi-factor regulation, which has advantages in treating complex diseases. The combination of ancient smart soup with donepezil was able to significantly improve the cognitive function in demented animals. Smart Soup is prepared from three herbs: Rhizoma Acori Tatarinowii, Poria cum Radix Pini, Radix Polygalae. These three herbs are each 15 grams and ground into a very fine powder. This approach reduced the formation of characteristic pathological changes at the pathological level, therefore, the combination of ancient Chinese medicine formulae with modern medical treatment may bring new hope to the treatment of demented patients. The main design of this study are following: Patients over 40 years of age and eligible for NIA-AA 2011 probable AD and probable MCI were included in this study and were divided into 6 groups of 30 patients each. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and placebo; group V mild cognitive impairment (MCI) patients were given smart soup, and group VI MCI patients were given placebo. Evaluations were set before enrollment, every three months till one year and the evaluators were single-blind. The scales involved in the evaluation of cognitive function and quality of life, sleep condition, and emotional behavior included ADAS-cog, MMSE, CDR, ADL, CMAI, NPI, and EQ-5D, which were evaluated five times. MRI, EEG, blood oxidative stress indicators, and biological markers were collected at the same time at enrollment and at the end of the study. Genotype collection was completed at enrollment. Safety was also evaluated with monthly testing of ECG, routine blood, liver and kidney function, urinary routine, and recording of side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment
Keywords
Alzheimer's disease, Traditional Chinese Medicine, Smart soup

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients were divided into 6 groups according to the enrollment criteria, with 30 cases in each group. Group I AD patients were given donepezil 10 mg, memantine 20 mg and smart soup, group II AD patients were given donepezil 10 mg, memantine 20 mg and placebo; group III AD patients were given donepezil 10 mg and smart soup, group IV AD patients were given donepezil 10 mg and and placebo; group V MCI patients were given smart soup, and group VI MCI patients were given placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I severe AD
Arm Type
Active Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and smart soup
Arm Title
Group II severe AD
Arm Type
Sham Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable severe AD will be given donepezil 10 mg, memantine 20 mg and placebo
Arm Title
Group III Mild or moderate AD
Arm Type
Active Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and smart soup
Arm Title
Group IV Mild or moderate AD
Arm Type
Sham Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable mild or moderate AD will be given donepezil 10 mg and placebo
Arm Title
Group V MCI
Arm Type
Active Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup
Arm Title
Group VI MCI
Arm Type
Sham Comparator
Arm Description
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo
Intervention Type
Drug
Intervention Name(s)
smart soup
Other Intervention Name(s)
traditional chinese medicine
Intervention Description
Severe AD, mild or moderate AD and MCI will be given smart soup
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
donepezil pill
Intervention Description
Severe AD and mild or moderate AD will be given donepezil
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Memantine Pill
Intervention Description
Severe AD will be given memantine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients with MCI will be given placebo
Primary Outcome Measure Information:
Title
Changes of cognitive screening
Description
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes of comprehensive cognitive assessment
Description
Use the neuropsychological scales, Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog 0-75), to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes in the degree of dementia
Description
Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes in behavior
Description
Use the Cohen-Mansfield Agitation Inventory (CMAI,29-203) to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes in Psychiatric symptoms
Description
Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes of daily living skills
Description
Use Activity of Daily Living Scale(ADL,20-80)to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Changes in health status
Description
Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Time Frame
Through study completion, an average of 1 years
Title
Tau and Beta-amyloid biomarkers in CSF and plasma
Description
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) and plasma of patients with dementia and controls
Time Frame
Through study completion, an average of 1 years
Title
Magnetic resonance imaging and Electroencephalogram(EEG)
Description
Evaluate the imaging and EEG changes of dementia patients. Specifically, EEG can be used to monitor the activity of brain waves in different parts of the cerebral cortex (e.g. power in alpha band, distribution and power of slow theta/delta waves etc.)
Time Frame
Through study completion, an average of 1 years
Title
Oxidative stress markers in blood
Description
Concentration of Dopamine in blood of patients with dementia and controls
Time Frame
Through study completion, an average of 1 years
Title
Alterations of neurotransmitters in the blood
Description
Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls
Time Frame
Through study completion, an average of 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: NIA-AA 2011 AD probable Alzheimer's disease, mild to moderate, stable use donepezil 10mg/d for 3 months NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months NIA-AA 2011 MCI probable criteria stable care giver Traditional Chinese medicine diagnosis: pixu tanzhuo Exclusion Criteria: Severe systemic disease (heart, liver ,kidney function failure) contradictions of MRI examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenhui Mao, MD
Phone
+86-010-69151389
Email
maochenhui@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Gao, MD
Phone
+86-010-69151389
Email
gj107@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Gao, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenhui Mao, Doctor
Email
maochenhui@pumch.cn
First Name & Middle Initial & Last Name & Degree
Jing Gao, Doctor
Email
gj107@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25386946
Citation
Hou Y, Wang Y, Zhao J, Li X, Cui J, Ding J, Wang Y, Zeng X, Ling Y, Shen X, Chen S, Huang C, Pei G. Smart Soup, a traditional Chinese medicine formula, ameliorates amyloid pathology and related cognitive deficits. PLoS One. 2014 Nov 11;9(11):e111215. doi: 10.1371/journal.pone.0111215. eCollection 2014. Erratum In: PLoS One. 2020 Aug 3;15(8):e0237035.
Results Reference
background
PubMed Identifier
25690664
Citation
Wang Y, Wang Y, Sui Y, Yu H, Shen X, Chen S, Pei G, Zhao J, Ding J. The combination of aricept with a traditional Chinese medicine formula, smart soup, may be a novel way to treat Alzheimer's disease. J Alzheimers Dis. 2015;45(4):1185-95. doi: 10.3233/JAD-143183.
Results Reference
background
PubMed Identifier
23839964
Citation
Ling Y, Li Z, Chen M, Sun Z, Fan M, Huang C. Analysis of multiple constituents in Cong-Ming-Tang, a Chinese herbal formula for the treatment of amnesia, by high-performance liquid chromatography with quadrupole time-of-flight mass spectrometry. Phytochem Anal. 2013 Nov-Dec;24(6):677-88. doi: 10.1002/pca.2454. Epub 2013 Jul 9.
Results Reference
background
PubMed Identifier
21514250
Citation
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Results Reference
background

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Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease

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