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

NCT03090516 | Unknown Phase 2

• 1 other identifier: Ginkgo biloba
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's

Keywords

Ginkgo biloba dispersible tablets; Alzheimer's

Outcome Measures

Primary Outcomes (9)

• Scales to assess

  MMSE（Mini-mental State Examinatlon）

  change from baseline MMSE at 12weeks

• Electroencephalography P300

  participants distinguish two voice and count them at the same time.we record their electroencephalography

  change from baseline at 12weeks

• liver function (blood)

  liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride）

  change from baseline at 12weeks

• 1.5T MRI changes

  Magnetic Resonance Imaging

  changes before and after 12weeks

• Alzheimer disease assessment scale (ADAS-cog)

  ADAS-cog

  change from baseline ADAS-cog at 12 weeks

• activities of daily living scale (ADL)

  ADL

  change from baseline ADL at 12 weeks

• Change in neuropsychiatrc interventory (NPI)

  NPI

  change from baseline NPI at 12weeks

• Change in geriatric depression scale (GDS)

  GDS

  change from baseline GDS at 12 weeks

• renal function

  blood urea nitrogen

  change from baseline at 12weeks

Secondary Outcomes (1)

• ECG

  change from baseline at 12weeks

Study Arms (3)

Arm A ：Donepezil

EXPERIMENTAL

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

Drug: Donepezil

Arm B ：Donepezil and Ginkgo biloba dispersible tablets

EXPERIMENTAL

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

Drug: Ginkgo biloba dispersible tablets and Donepezil

Arm C：Ginkgo biloba dispersible tablets

EXPERIMENTAL

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

Drug: Ginkgo biloba dispersible tablets

Interventions

Ginkgo biloba dispersible tablets DRUG

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

Also known as: Ginkgo biloba dispersible tablets and Donepezil;Donepezil

Arm C：Ginkgo biloba dispersible tablets

Donepezil DRUG

Arm A：Aricept 5mg/day

Also known as: Ginkgo biloba dispersible tablets;Ginkgo biloba dispersible tablets and Donepezil

Arm A ：Donepezil

Ginkgo biloba dispersible tablets and Donepezil DRUG

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

Also known as: Donepezil;Ginkgo biloba dispersible tablets

Arm B ：Donepezil and Ginkgo biloba dispersible tablets

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Ting Wu

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Ginkgo Extract; Donepezil

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Ting Wu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Ting Wu

CONTACT

18851122018; wuting80000@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 4, 2017
• First Posted: March 24, 2017
• Study Start: August 10, 2016
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

CN (1)