Have you or your loved ones been diagnosed with alzheimer's?

You may be eligible to participate in a alzheimer's clinical trial.

Have you or your loved ones been diagnosed with alzheimer's? You may be eligible to participate in a alzheimer's clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Alzheimer's Clinical Trial in Nanjing Jiangsu

NCT03090516 | Phase 2 phase 3 | Interventional

Have you or your loved ones been diagnosed with alzheimer's?

You may be eligible to participate in a alzheimer's clinical trial.

Have you or your loved ones been diagnosed with alzheimer's? You may be eligible to participate in a alzheimer's clinical trial.

Recruiting

Male & Female

50 - 85

Years old

This study is looking to recruit 240 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function<br /> in patients with mild-to-moderate elderly, to observe the effects of different intervention<br /> time on cognitive function, for alzheimer's patients in drug rehabilitation treatment<br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

renal function

blood urea nitrogen

change from baseline at 12weeks

Primary

Change in geriatric depression scale (GDS)

GDS

change from baseline GDS at 12 weeks

Primary

Scales to assess

MMSE（Mini-mental State Examinatlon）

change from baseline MMSE at 12weeks

Primary

activities of daily living scale (ADL)

ADL

change from baseline ADL at 12 weeks

Primary

Alzheimer disease assessment scale (ADAS-cog)

ADAS-cog

change from baseline ADAS-cog at 12 weeks

Primary

1.5T MRI changes

Magnetic Resonance Imaging

changes before and after 12weeks

Primary

liver function (blood)

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

change from baseline 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

Change in neuropsychiatrc interventory (NPI)

NPI

change from baseline NPI at 12weeks

Secondary

ECG

Electrocardiograph

change from baseline at 12weeks

Study Criteria

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).