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

NCT ID: NCT03090516

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-10

Study Completion Date

2020-03-10

Brief Summary

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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

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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.

Conditions

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Alzheimer's

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A :Donepezil

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

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

Arm A:Aricept 5mg/day

Arm B :Donepezil and Ginkgo biloba dispersible tablets

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

Group Type EXPERIMENTAL

Ginkgo biloba dispersible tablets and Donepezil

Intervention Type DRUG

Arm B:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.Aricept 5mg/day.

Arm C:Ginkgo biloba dispersible tablets

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

Group Type EXPERIMENTAL

Ginkgo biloba dispersible tablets

Intervention Type DRUG

Arm C:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.

Interventions

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Ginkgo biloba dispersible tablets

Arm C:Ginkgo biloba dispersible tablets,0.15g at a time, three times a day.

Intervention Type DRUG

Donepezil

Arm A:Aricept 5mg/day

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Ginkgo biloba dispersible tablets and Donepezil;Donepezil Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil Donepezil;Ginkgo biloba dispersible tablets

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ting Wu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ting Wu

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Ting Wu

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Wu

Role: CONTACT

18851122018

Facility Contacts

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Ting Wu, professor

Role: primary

18851122018

Wanrong Zhang, master

Role: backup

15851875395

Other Identifiers

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Ginkgo biloba

Identifier Type: -

Identifier Source: org_study_id

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