A Phase 2 interventional study of smart soup and Donepezil in Alzheimer Disease and Mild Cognitive Impairment, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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).
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 180 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Exclusion Criteria:
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
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
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
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
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup
Drug: smart soup
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo
Drug: Placebo
Severe AD, mild or moderate AD and MCI will be given smart soup
Also known as: traditional chinese medicine
Severe AD and mild or moderate AD will be given donepezil
Also known as: donepezil pill
Severe AD will be given memantine
Also known as: Memantine Pill
patients with MCI will be given placebo
Changes of cognitive screening
Using the neuropsychological scale, mini-mental state examination (MMSE,0-30), to assess every three months after trial entry
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.)
Time frame: Through study completion, an average of 1 years
Oxidative stress markers in blood
Concentration of Dopamine in blood of patients with dementia and controls
Time frame: 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
Time frame: Through study completion, an average of 1 years
Plan to share: No
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Peking Union Medical College Hospital