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

Nanjing Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Alzheimer's

Treatments: Drug: Donepezil; Drug: Ginkgo biloba dispersible tablets and Donepezil; Drug: Ginkgo biloba dispersible tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03090516

Ginkgo biloba

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups

Arm A ：Donepezil

Experimental group

Description:

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

Treatment:

Drug: Donepezil

Arm B ：Donepezil and Ginkgo biloba dispersible tablets

Experimental group

Description:

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

Treatment:

Drug: Ginkgo biloba dispersible tablets and Donepezil

Arm C：Ginkgo biloba dispersible tablets

Experimental group

Description:

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

Treatment:

Drug: Ginkgo biloba dispersible tablets