Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
- Conditions
- Mild Cognitive ImpairmentAlzheimer Disease
- Interventions
- Registration Number
- NCT05538507
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- Severe systemic disease (heart, liver ,kidney function failure)
- contradictions of MRI examination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group IV Mild or moderate AD 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 placebo Group III Mild or moderate AD 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 smart soup Group II severe AD Placebo 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 Group I severe AD 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 smart soup Group VI MCI Placebo Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo Group V MCI smart soup Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup Group I severe AD Donepezil 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 Group I severe AD Memantine 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 Group II severe AD Memantine 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 Group II severe AD Donepezil 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 Group IV Mild or moderate AD Donepezil 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 Group III Mild or moderate AD Donepezil 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
- Primary Outcome Measures
Name Time Method Changes in health status Through study completion, an average of 1 years Use EuroQoL 5-dimension (EQ-5D,0-100) to assess every three months after trial entry
Magnetic resonance imaging and Electroencephalogram（EEG） 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.)
Changes of comprehensive cognitive assessment 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
Tau and Beta-amyloid biomarkers in CSF and plasma 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
Oxidative stress markers in blood Through study completion, an average of 1 years Concentration of Dopamine in blood of patients with dementia and controls
Changes of cognitive screening 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
Changes in behavior 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
Changes in Psychiatric symptoms Through study completion, an average of 1 years Use the Neuropsychiatric Index (NPI) to assess every three months after trial entry
Alterations of neurotransmitters in the blood Through study completion, an average of 1 years Concentration (ng/ml) of 5-hydroxy tryptamine (HT) in blood of patients with dementia and controls
Changes in the degree of dementia Through study completion, an average of 1 years Use the neuropsychological scales, CDR(0-3), to assess every three months after trial entry
Changes of daily living skills 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China