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

NCT05538507 | Unknown Phase 2

• 1 other identifier: Smart Soup
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Alzheimer's disease; Traditional Chinese Medicine; Smart soup

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Oxidative stress markers in blood

  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

  Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls

  Through study completion, an average of 1 years

Study Arms (6)

Group I severe AD

ACTIVE COMPARATOR

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; Drug: Donepezil; Drug: Memantine

Group II severe AD

SHAM COMPARATOR

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; Drug: Memantine; Drug: Placebo

Group III Mild or moderate AD

ACTIVE COMPARATOR

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; Drug: Donepezil

Group IV Mild or moderate AD

SHAM COMPARATOR

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; Drug: Placebo

Group V MCI

ACTIVE COMPARATOR

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

Drug: smart soup

Group VI MCI

SHAM COMPARATOR

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

Drug: Placebo

Interventions

smart soup DRUG

Severe AD, mild or moderate AD and MCI will be given smart soup

Also known as: traditional chinese medicine

Group I severe AD; Group III Mild or moderate AD; Group V MCI

Donepezil DRUG

Severe AD and mild or moderate AD will be given donepezil

Also known as: donepezil pill

Group I severe AD; Group II severe AD; Group III Mild or moderate AD; Group IV Mild or moderate AD

Memantine DRUG

Severe AD will be given memantine

Also known as: Memantine Pill

Group I severe AD; Group II severe AD

Placebo DRUG

patients with MCI will be given placebo

Group II severe AD; Group IV Mild or moderate AD; Group VI MCI

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Tongji University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related 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.

  PMID: 25386946 BACKGROUND

• 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.

  PMID: 25690664 BACKGROUND

• 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.

  PMID: 23839964 BACKGROUND

• 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.

  PMID: 21514250 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Medicine, Chinese Traditional; Donepezil; Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Amantadine; Adamantane; Bridged-Ring Compounds

Study Officials

• Jing Gao, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhui Mao, MD

CONTACT

+86-010-69151389; maochenhui@pumch.cn

Jing Gao, MD

CONTACT

+86-010-69151389; gj107@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: September 14, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)