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

Primary Purpose

Alzheimer's

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ginkgo biloba dispersible tablets
Donepezil
Ginkgo biloba dispersible tablets and Donepezil
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's focused on measuring Ginkgo biloba dispersible tablets, Alzheimer's

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ting WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A :Donepezil

Arm B :Donepezil and Ginkgo biloba dispersible tablets

Arm C:Ginkgo biloba dispersible tablets

Arm Description

A:People are randomly divided into three groups according to the educational conditiono,gender and age.

B:People are randomly divided into three groups according to the educational conditiono,gender and age.

C:People are randomly divided into three groups according to the educational conditiono,gender and age.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ECG
Electrocardiograph

Full Information

First Posted
March 4, 2017
Last Updated
August 5, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03090516
Brief Title
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease
Official Title
Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
March 10, 2020 (Anticipated)
Study Completion Date
March 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's
Keywords
Ginkgo biloba dispersible tablets, Alzheimer's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A :Donepezil
Arm Type
Experimental
Arm Description
A:People are randomly divided into three groups according to the educational conditiono,gender and age.
Arm Title
Arm B :Donepezil and Ginkgo biloba dispersible tablets
Arm Type
Experimental
Arm Description
B:People are randomly divided into three groups according to the educational conditiono,gender and age.
Arm Title
Arm C:Ginkgo biloba dispersible tablets
Arm Type
Experimental
Arm Description
C:People are randomly divided into three groups according to the educational conditiono,gender and age.
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba dispersible tablets
Other Intervention Name(s)
Ginkgo biloba dispersible tablets and Donepezil;Donepezil
Intervention Description
Arm C:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil
Intervention Description
Arm A:Aricept 5mg/day
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba dispersible tablets and Donepezil
Other Intervention Name(s)
Donepezil;Ginkgo biloba dispersible tablets
Intervention Description
Arm B:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.Aricept 5mg/day.
Primary Outcome Measure Information:
Title
Scales to assess
Description
MMSE(Mini-mental State Examinatlon)
Time Frame
change from baseline MMSE at 12weeks
Title
Electroencephalography P300
Description
participants distinguish two voice and count them at the same time.we record their electroencephalography
Time Frame
change from baseline at 12weeks
Title
liver function (blood)
Description
liver function(aspartate transaminase,Alanine aminotransferase,low density lipoprotein,Serum total cholesterol,Triglyceride)
Time Frame
change from baseline at 12weeks
Title
1.5T MRI changes
Description
Magnetic Resonance Imaging
Time Frame
changes before and after 12weeks
Title
Alzheimer disease assessment scale (ADAS-cog)
Description
ADAS-cog
Time Frame
change from baseline ADAS-cog at 12 weeks
Title
activities of daily living scale (ADL)
Description
ADL
Time Frame
change from baseline ADL at 12 weeks
Title
Change in neuropsychiatrc interventory (NPI)
Description
NPI
Time Frame
change from baseline NPI at 12weeks
Title
Change in geriatric depression scale (GDS)
Description
GDS
Time Frame
change from baseline GDS at 12 weeks
Title
renal function
Description
blood urea nitrogen
Time Frame
change from baseline at 12weeks
Secondary Outcome Measure Information:
Title
ECG
Description
Electrocardiograph
Time Frame
change from baseline at 12weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Wu
Phone
18851122018
Email
wuting80000@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Wu
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Ting Wu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Wu, professor
Phone
18851122018
Email
wuting80000@126.com
First Name & Middle Initial & Last Name & Degree
Wanrong Zhang, master
Phone
15851875395
Email
zwr10010533@163.com

12. IPD Sharing Statement

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

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