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

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ClinicalTrials.gov Identifier: NCT03090516
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ting Wu, The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Drug: Ginkgo biloba dispersible tablets Drug: Donepezil Drug: Ginkgo biloba dispersible tablets and Donepezil Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
Actual Study Start Date : August 10, 2016
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : March 10, 2020


Arm Intervention/treatment
Experimental: Arm A :Donepezil
A:People are randomly divided into three groups according to the educational conditiono,gender and age.
Drug: Donepezil
Arm A:Aricept 5mg/day
Other Name: Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil

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.
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.
Other Name: Donepezil;Ginkgo biloba dispersible tablets

Experimental: Arm C:Ginkgo biloba dispersible tablets
C:People are randomly divided into three groups according to the educational conditiono,gender and age.
Drug: Ginkgo biloba dispersible tablets
Arm C:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.
Other Name: Ginkgo biloba dispersible tablets and Donepezil;Donepezil




Primary Outcome Measures :
  1. Scales to assess [ Time Frame: change from baseline MMSE at 12weeks ]
    MMSE(Mini-mental State Examinatlon)

  2. Electroencephalography P300 [ Time Frame: change from baseline at 12weeks ]
    participants distinguish two voice and count them at the same time.we record their electroencephalography

  3. liver function (blood) [ Time Frame: change from baseline at 12weeks ]
    liver function(aspartate transaminase,Alanine aminotransferase,low density lipoprotein,Serum total cholesterol,Triglyceride)

  4. 1.5T MRI changes [ Time Frame: changes before and after 12weeks ]
    Magnetic Resonance Imaging

  5. Alzheimer disease assessment scale (ADAS-cog) [ Time Frame: change from baseline ADAS-cog at 12 weeks ]
    ADAS-cog

  6. activities of daily living scale (ADL) [ Time Frame: change from baseline ADL at 12 weeks ]
    ADL

  7. Change in neuropsychiatrc interventory (NPI) [ Time Frame: change from baseline NPI at 12weeks ]
    NPI

  8. Change in geriatric depression scale (GDS) [ Time Frame: change from baseline GDS at 12 weeks ]
    GDS

  9. renal function [ Time Frame: change from baseline at 12weeks ]
    blood urea nitrogen


Secondary Outcome Measures :
  1. ECG [ Time Frame: change from baseline at 12weeks ]
    Electrocardiograph



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090516


Contacts
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Contact: Ting Wu 18851122018 wuting80000@126.com

Locations
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China, Jiangsu
Ting Wu Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Ting Wu, professor    18851122018    wuting80000@126.com   
Contact: Wanrong Zhang, master    15851875395    zwr10010533@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Director: Ting Wu The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: Ting Wu, Director, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03090516     History of Changes
Other Study ID Numbers: Ginkgo biloba
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ting Wu, The First Affiliated Hospital with Nanjing Medical University:
Ginkgo biloba dispersible tablets
Alzheimer's
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents