Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets

Conditions
-----------------
Alzheimer's

Intervention / Treatment
-----------------
* Drug: Ginkgo biloba dispersible tablets
* Drug: Donepezil
* Drug: Ginkgo biloba dispersible tablets and Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) CDR 1-2 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. Exclusion Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A ：Donepezil<br>A：People are randomly divided into three groups according to the educational conditiono，gender and age. | Drug: Donepezil<br>* Arm A：Aricept 5mg/day<br>* Other names: Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil;|
| Experimental: Arm B ：Donepezil and Ginkgo biloba dispersible tablets<br>B：People are randomly divided into three groups according to the educational conditiono，gender and age. | Drug: Ginkgo biloba dispersible tablets and Donepezil<br>* Arm B：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.Aricept 5mg/day.<br>* Other names: Donepezil;Ginkgo biloba dispersible tablets;|
| Experimental: Arm C：Ginkgo biloba dispersible tablets<br>C：People are randomly divided into three groups according to the educational conditiono，gender and age. | Drug: Ginkgo biloba dispersible tablets<br>* Arm C：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.<br>* Other names: Ginkgo biloba dispersible tablets and Donepezil;Donepezil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scales to assess | MMSE（Mini-mental State Examinatlon） | change from baseline MMSE at 12weeks | 
| Electroencephalography P300 | participants distinguish two voice and count them at the same time.we record their electroencephalography | change from baseline at 12weeks | 
| liver function (blood) | liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride） | change from baseline at 12weeks | 
| 1.5T MRI changes | Magnetic Resonance Imaging | changes before and after 12weeks | 
| Alzheimer disease assessment scale (ADAS-cog) | ADAS-cog | change from baseline ADAS-cog at 12 weeks | 
| activities of daily living scale (ADL) | ADL | change from baseline ADL at 12 weeks | 
| Change in neuropsychiatrc interventory (NPI) | NPI | change from baseline NPI at 12weeks | 
| Change in geriatric depression scale (GDS) | GDS | change from baseline GDS at 12 weeks | 
| renal function | blood urea nitrogen | change from baseline at 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG | Electrocardiograph | change from baseline at 12weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ginkgo biloba dispersible tablets, Alzheimer's