Clinical trial NCT03090516: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Alzheimer's
Keywords: Ginkgo biloba dispersible tablets
Alzheimer's
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Scales to assess
timeFrame: change from baseline MMSE at 12weeks
measure: Electroencephalography P300
timeFrame: change from baseline at 12weeks
measure: liver function (blood)
timeFrame: change from baseline at 12weeks
measure: 1.5T MRI changes
timeFrame: changes before and after 12weeks
measure: Alzheimer disease assessment scale (ADAS-cog)
timeFrame: change from baseline ADAS-cog at 12 weeks
measure: activities of daily living scale (ADL)
timeFrame: change from baseline ADL at 12 weeks
measure: Change in neuropsychiatrc interventory (NPI)
timeFrame: change from baseline NPI at 12weeks
measure: Change in geriatric depression scale (GDS)
timeFrame: change from baseline GDS at 12 weeks
measure: renal function
timeFrame: change from baseline at 12weeks
Secondary outcomes:
measure: ECG
timeFrame: change from baseline at 12weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Ting Wu
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ting Wu
role: STUDY_DIRECTOR
References: