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

August 5, 2019 updated by: Ting Wu, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Ting Wu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2016

Primary Completion (Anticipated)

March 10, 2020

Study Completion (Anticipated)

March 10, 2020

Study Registration Dates

First Submitted

March 4, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ginkgo biloba

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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