Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
试验速览
- 阶段
- 2 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Scales to assess
研究概览
简要总结
This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution.
详细描述
The assessment of cognitive scales included Minimum Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale-cognition(ADAS-cog), Neuropsychiatric inventory(NPI), quality of Life of Life in Alzheimer's disease(Qol-ADL), activities of Daily living(ADL), Geriatric Depression scale(GDS).Biochemical test included cholesterol, triglycerides, and low density lipoprotein.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were diagnosed with dementia caused by AD in 2011, the latest diagnostic criteria for Alzheimer's disease (NIA-AA), according to the patient's clinical and cranial imaging findings
- •Improved Hachinski ischemic scale score <4
- •All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia
- •MMSE(High school≤24,Primary school≤20;illiteracy≤17)
- •The subjects and nurses signed informed consent, and the nursing staff were able to take responsibility for the supervision of the participants
- •The subjects were stable
- •Cooperate, willing to complete all parts of the research, and have the ability to complete the study alone or with the help of the nursing staff
- •To cooperate with the study, do not live alone, such as living alone should keep in touch with the nurse every day.
排除标准
- •Heart lung kidney disease, may interfere to evaluate the efficacy and safety of patients at risk or special disease,for example:Congestive heart failure et al.
- •According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia
- •Improved Hachinski ischemic scale score（MHIS）≥4
- •Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis
- •Neurological or other medical disorders that affect the function of the central nervous system,like Moderate anemia,Vitamin B12 or folic acid deficiency, et al. Not with the cognitive function examination (including blindness, deafness, severe language disorders).
研究组 & 干预措施
Arm A ：Donepezil
A：People are randomly divided into three groups according to the educational conditiono，gender and age.
干预措施: Donepezil (Drug)
Arm B ：Donepezil and Ginkgo biloba dispersible tablets
B：People are randomly divided into three groups according to the educational conditiono，gender and age.
干预措施: Ginkgo biloba dispersible tablets and Donepezil (Drug)
Arm C：Ginkgo biloba dispersible tablets
C：People are randomly divided into three groups according to the educational conditiono，gender and age.
干预措施: Ginkgo biloba dispersible tablets (Drug)
结局指标
主要结局
Scales to assess
时间窗: change from baseline MMSE at 12weeks
MMSE（Mini-mental State Examinatlon）
Electroencephalography P300
时间窗: change from baseline at 12weeks
participants distinguish two voice and count them at the same time.we record their electroencephalography
liver function (blood)
时间窗: change from baseline at 12weeks
liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride）
1.5T MRI changes
时间窗: changes before and after 12weeks
Magnetic Resonance Imaging
Alzheimer disease assessment scale (ADAS-cog)
时间窗: change from baseline ADAS-cog at 12 weeks
ADAS-cog
activities of daily living scale (ADL)
时间窗: change from baseline ADL at 12 weeks
ADL
Change in neuropsychiatrc interventory (NPI)
时间窗: change from baseline NPI at 12weeks
NPI
Change in geriatric depression scale (GDS)
时间窗: change from baseline GDS at 12 weeks
GDS
renal function
时间窗: change from baseline at 12weeks
blood urea nitrogen
次要结局
- ECG(change from baseline at 12weeks)
研究者
Ting Wu
Director
The First Affiliated Hospital with Nanjing Medical University