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Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease
Clinical Study on Improving the Cognitive Function of Patients With Mild to Moderate Alzheimer's Disease by Using Ginkgo Biloba Dispersible Tablets
Asset
Donepezil
Listed sites
1
Recruiting sites
1
Enrollment
240
estimated
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE ≤24
Primary endpoints
•Mini-Mental State Examination (MMSE)•Electroencephalography P300•Liver function (blood)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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).
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsScales to assess
Time frame:change from baseline MMSE at 12weeks
Mini-Mental State Examination (MMSE)
descriptive
Alzheimer disease assessment scale (ADAS-cog)
Time frame:change from baseline ADAS-cog at 12 weeks
ADAS-Cog
descriptive
Function / daily living
1 endpointactivities of daily living scale (ADL)
Time frame:change from baseline ADL at 12 weeks
descriptive
Behavior / neuropsychiatric
2 endpointsChange in neuropsychiatrc interventory (NPI)
Time frame:change from baseline NPI at 12weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Change in geriatric depression scale (GDS)
Time frame:change from baseline GDS at 12 weeks
change from baseline, improvement
Neuroimaging
1 endpoint1.5T MRI changes
Time frame:changes before and after 12weeks
descriptive
Other (unclassified)
4 endpointsElectroencephalography P300
Time frame:change from baseline at 12weeks
descriptive
liver function (blood)
Time frame:change from baseline at 12weeks
descriptive
renal function
Time frame:change from baseline at 12weeks
descriptive
ECG
Time frame:change from baseline at 12weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.