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

September 10, 2022 updated by: gaojing, Peking Union Medical College Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jing Gao, MD
  • Phone Number: +86-010-69151389
  • Email: gj107@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I severe AD
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
Drug: smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Other Names:
  • traditional chinese medicine
Drug: Donepezil
Severe AD and mild or moderate AD will be given donepezil
Other Names:
  • donepezil pill
Drug: Memantine
Severe AD will be given memantine
Other Names:
  • Memantine Pill
Sham Comparator: Group II severe AD
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
Drug: Donepezil
Severe AD and mild or moderate AD will be given donepezil
Other Names:
  • donepezil pill
Drug: Memantine
Severe AD will be given memantine
Other Names:
  • Memantine Pill
Drug: Placebo
patients with MCI will be given placebo
Active Comparator: Group III Mild or moderate AD
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
Drug: smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Other Names:
  • traditional chinese medicine
Drug: Donepezil
Severe AD and mild or moderate AD will be given donepezil
Other Names:
  • donepezil pill
Sham Comparator: Group IV Mild or moderate AD
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
Drug: Donepezil
Severe AD and mild or moderate AD will be given donepezil
Other Names:
  • donepezil pill
Drug: Placebo
patients with MCI will be given placebo
Active Comparator: Group V MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup
Drug: smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
Other Names:
  • traditional chinese medicine
Sham Comparator: Group VI MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo
Drug: Placebo
patients with MCI will be given placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of cognitive screening
Time Frame: Through study completion, an average of 1 years
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Through study completion, an average of 1 years
Changes of comprehensive cognitive assessment
Time Frame: Through study completion, an average of 1 years
Use the neuropsychological scales, Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog 0-75)， to assess every three months after trial entry
Through study completion, an average of 1 years
Changes in the degree of dementia
Time Frame: Through study completion, an average of 1 years
Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Through study completion, an average of 1 years
Changes in behavior
Time Frame: Through study completion, an average of 1 years
Use the Cohen-Mansfield Agitation Inventory (CMAI，29-203) to assess every three months after trial entry
Through study completion, an average of 1 years
Changes in Psychiatric symptoms
Time Frame: Through study completion, an average of 1 years
Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Through study completion, an average of 1 years
Changes of daily living skills
Time Frame: Through study completion, an average of 1 years
Use Activity of Daily Living Scale（ADL，20-80）to assess every three months after trial entry
Through study completion, an average of 1 years
Changes in health status
Time Frame: Through study completion, an average of 1 years
Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Through study completion, an average of 1 years
Tau and Beta-amyloid biomarkers in CSF and plasma
Time Frame: Through study completion, an average of 1 years
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) and plasma of patients with dementia and controls
Through study completion, an average of 1 years
Magnetic resonance imaging and Electroencephalogram（EEG）
Time Frame: Through study completion, an average of 1 years
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.)
Through study completion, an average of 1 years
Oxidative stress markers in blood
Time Frame: Through study completion, an average of 1 years
Concentration of Dopamine in blood of patients with dementia and controls
Through study completion, an average of 1 years
Alterations of neurotransmitters in the blood
Time Frame: Through study completion, an average of 1 years
Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls
Through study completion, an average of 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Tongji University

Investigators

  • Principal Investigator: Jing Gao, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

September 10, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 10, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Smart Soup

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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