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

Alzheimer's Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090516
• Other study ID #: Ginkgo biloba
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 10, 2016
• Est. completion date: March 10, 2020

Study information

• Verified date: August 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Ting Wu
• Phone: 18851122018
• Email: wuting80000[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's

Intervention

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

Locations

Country	Name	City	State
China	Ting Wu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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