Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in health status
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe systemic disease (heart, liver ,kidney function failure)
- •contradictions of MRI examination
研究组 & 干预措施
Group I severe AD
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
干预措施: smart soup (Drug)
Group I severe AD
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
干预措施: Donepezil (Drug)
Group I severe AD
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
干预措施: Memantine (Drug)
Group II severe AD
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
干预措施: Donepezil (Drug)
Group II severe AD
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
干预措施: Memantine (Drug)
Group II severe AD
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
干预措施: Placebo (Drug)
Group III Mild or moderate AD
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
干预措施: smart soup (Drug)
Group III Mild or moderate AD
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
干预措施: Donepezil (Drug)
Group IV Mild or moderate AD
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
干预措施: Donepezil (Drug)
Group IV Mild or moderate AD
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
干预措施: Placebo (Drug)
Group V MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given smart soup
干预措施: smart soup (Drug)
Group VI MCI
Patients over 40 years of age and eligible for NIA-AA 2011 probable MCI will be given placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in health status
时间窗: 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）
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 1 years
Concentration of Dopamine in blood of patients with dementia and controls
Changes of cognitive screening
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
gaojing
Professor, Department of Neurology
Peking Union Medical College Hospital