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UnknownPhase 2 / PHASE3

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 diseaseMMSE ≤24

Primary endpoints

Mini-Mental State Examination (MMSE)Electroencephalography P300Liver 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

Org study IDGinkgo biloba
NCT IDNCT03090516

Timeline

Milestones

Study start2016-08-10actual
Study first posted2017-03-24actual
Last update posted2019-08-07actual
Primary completion2020-03-10estimated
Study completion2020-03-10estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
4
Global cognition
2
Behavior / neuropsychiatric
2
Function / daily living
1
Neuroimaging
1

Global cognition

2 endpoints
Primary/protocol endpoint

Scales to assess

Time frame:change from baseline MMSE at 12weeks

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Alzheimer disease assessment scale (ADAS-cog)

Time frame:change from baseline ADAS-cog at 12 weeks

ADAS-Cog

descriptive

Function / daily living

1 endpoint
Primary/protocol endpoint

activities of daily living scale (ADL)

Time frame:change from baseline ADL at 12 weeks

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change in neuropsychiatrc interventory (NPI)

Time frame:change from baseline NPI at 12weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Primary/protocol endpoint

Change in geriatric depression scale (GDS)

Time frame:change from baseline GDS at 12 weeks

change from baseline, improvement

Neuroimaging

1 endpoint
Primary/protocol endpoint

1.5T MRI changes

Time frame:changes before and after 12weeks

descriptive

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Electroencephalography P300

Time frame:change from baseline at 12weeks

descriptive

Primary/protocol endpoint/low confidence

liver function (blood)

Time frame:change from baseline at 12weeks

descriptive

Primary/protocol endpoint/low confidence

renal function

Time frame:change from baseline at 12weeks

descriptive

Secondary/protocol endpoint/low confidence

ECG

Time frame:change from baseline at 12weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.