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

Overview

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.

Full Title of Study: “Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer’s Disease by Using Ginkgo Biloba Dispersible Tablets”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 10, 2020

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.

Interventions

  • Drug: Ginkgo biloba dispersible tablets
    • Arm C:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.
  • Drug: Donepezil
    • Arm A:Aricept 5mg/day
  • Drug: Ginkgo biloba dispersible tablets and Donepezil
    • Arm B:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.Aricept 5mg/day.

Arms, Groups and Cohorts

  • Experimental: Arm A :Donepezil
    • A:People are randomly divided into three groups according to the educational conditiono,gender and age.
  • Experimental: Arm B :Donepezil and Ginkgo biloba dispersible tablets
    • B:People are randomly divided into three groups according to the educational conditiono,gender and age.
  • Experimental: Arm C:Ginkgo biloba dispersible tablets
    • C:People are randomly divided into three groups according to the educational conditiono,gender and age.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • ECG
    • Time Frame: change from baseline at 12weeks
    • Electrocardiograph

Participating in This Clinical Trial

Inclusion Criteria

1. 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 2. Improved Hachinski ischemic scale score <4 3. All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia 4. MMSE(High school≤24,Primary school≤20;illiteracy≤17) 5. CDR 1-2 6. The subjects and nurses signed informed consent, and the nursing staff were able to take responsibility for the supervision of the participants 7. The subjects were stable 8. 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 9. To cooperate with the study, do not live alone, such as living alone should keep in touch with the nurse every day. Exclusion Criteria:

1. 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. 2. According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia 3. Improved Hachinski ischemic scale score(MHIS)≥4 4. Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis 5. 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).

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ting Wu, Director – The First Affiliated Hospital with Nanjing Medical University
  • Overall Official(s)
    • Ting Wu, Study Director, The First Affiliated Hospital with Nanjing Medical University
  • Overall Contact(s)
    • Ting Wu, 18851122018, wuting80000@126.com

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