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

Phase 2

• Conditions: Alzheimer's
• Interventions: Drug: Donepezil; Drug: Ginkgo biloba dispersible tablets and Donepezil; Drug: Ginkgo biloba dispersible tablets

• Registration Number: NCT03090516
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08-10
• Study First Submitted: 2017-03-04
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ECG	change from baseline at 12weeks	Electrocardiograph

Trial Locations

Locations (1)

Ting Wu; 🇨🇳 Nanjing, Jiangsu, China