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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538507
• Other study ID #: Smart Soup
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Chenhui Mao, MD
• Phone: +86-010-69151389
• Email: maochenhui[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• smart soup
Severe AD, mild or moderate AD and MCI will be given smart soup
• Donepezil
Severe AD and mild or moderate AD will be given donepezil
• Memantine
Severe AD will be given memantine
• Placebo
patients with MCI will be given placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Tongji University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of cognitive screening	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
Primary	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	Through study completion, an average of 1 years
Primary	Changes in the degree of dementia	Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry	Through study completion, an average of 1 years
Primary	Changes in behavior	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
Primary	Changes in Psychiatric symptoms	Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry	Through study completion, an average of 1 years
Primary	Changes of daily living skills	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
Primary	Changes in health status	Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry	Through study completion, an average of 1 years
Primary	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	Through study completion, an average of 1 years
Primary	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.)	Through study completion, an average of 1 years
Primary	Oxidative stress markers in blood	Concentration of Dopamine in blood of patients with dementia and controls	Through study completion, an average of 1 years
Primary	Alterations of neurotransmitters in the blood	Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls	Through study completion, an average of 1 years