Clinical trial NCT05538507: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Keywords: Alzheimer's disease
Traditional Chinese Medicine
Smart soup
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Tongji University
First posted: 2022-09-14
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes of cognitive screening
timeFrame: Through study completion, an average of 1 years
measure: Changes of comprehensive cognitive assessment
timeFrame: Through study completion, an average of 1 years
measure: Changes in the degree of dementia
timeFrame: Through study completion, an average of 1 years
measure: Changes in behavior
timeFrame: Through study completion, an average of 1 years
measure: Changes in Psychiatric symptoms
timeFrame: Through study completion, an average of 1 years
measure: Changes of daily living skills
timeFrame: Through study completion, an average of 1 years
measure: Changes in health status
timeFrame: Through study completion, an average of 1 years
measure: Tau and Beta-amyloid biomarkers in CSF and plasma
timeFrame: Through study completion, an average of 1 years
measure: Magnetic resonance imaging and Electroencephalogram（EEG）
timeFrame: Through study completion, an average of 1 years
measure: Oxidative stress markers in blood
timeFrame: Through study completion, an average of 1 years
measure: Alterations of neurotransmitters in the blood
timeFrame: Through study completion, an average of 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jing Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.