mild-to-moderate vascular dementia
Conditions
Interventions
experimental group:Compound Ginkgo Biloba Leaves Tablet
Placebo control group:Compound Ginkgo Biloba Leaves Tablet mimetic agent
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1)Meet the diagnostic criteria of vascular dementia (National Institute of Neurological Disorders and Stroke and the Association International pour la Researche etl' Enseigment en Neurosciences) (NINDS-AIREN) ; (2)Meet the scale for the differentiation of syndromes of vascular dementia(SDSVD) differentiation standard of blood stasis obstructing the brain collaterals syndrome (score = 7); (3)Score > 4 in Hachinski ischemia scale (Rosen modified version); (4)Meet the VASCOG imaging diagnostic criteria of VCI, have at least one of the following imaging findings in MRI examination: ? Cerebral infarction with a large vessel occlusion which is enough to cause VaMCI; ? An extensive cerebral infarction or cerebral infarction in a strategic region, located in the thalamus or basal ganglia, which might be enough to cause MCI; ? More than two lacunar infarcts which are located in regions other than the brain stem, and one of them is located in a strategic region; ? Extensive or fusion white matter hyperintensities, Fazekas grade 3;? Cerebral infarction located in strategic regions and two or more cerebral hemorrhages; (5)Subjects with mild-to-moderate vascular dementia: 11 points = MMSE = 26 points; (6)Aged 40~85 years (including 40 years and 85 years), all gender; (7)Subjects capable of cooperating to complete the tests in the trial; (8)The informed consent has been signed by the patients or legal guardians before the start of this trial.
Exclusion criteria
Exclusion criteria: (1)Subjects with dementia caused by a brain disease other than VaD, such as Alzheimer's disease, Lewy body dementia/Parkinson's disease dementia, frontotemporal dementia, Creutzfeldt-Jakob disease, etc.; (2)Subjects with subdural hematoma, communicating hydrocephalus, brain tumor, drug poisoning, alcoholism, and nutritional and metabolic diseases, such as thyroid disease, vitamin deficiency, etc.; (3)Subjects score > 17 in Hamilton depression scale (HAMD), or with depression, epilepsy, or other mental diseases (such as schizophrenia) that are unable or unwilling to cooperate; (4)Subjects with severe neurological function defects, such as dominant-hand hemiplegia, aphasia and vision and hearing impairment., etc., who are unable to complete the inspection. (5)Subjects who express a poor control of hypertension, patients with supine systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg before the first administration of the test drug; (6)Subjects with severe liver and kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3.0×Upper Limit of Normal (ULN), and/or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.; serum creatinine (Scr) > 2.0×ULN, and/or known severe renal insufficiency disease; (7)Subjects who are unable to swallow the oral drug, or with diseases affecting the absorption of an oral drug, such as active bowel disease, partial or complete bowel obstruction, etc.; (8)Subjects with other severe life-threatening diseases (such as malignant tumors, blood system diseases, digestive system diseases, or other severe system diseases) whose expected survival time does not exceed 12 months; (9)Women who are pregnant, planning pregnancy or lactating; (10)Subjects who are suspected of or have a history of alcohol or drug abuse; (11)Subjects who have allergic habitus or are allergic to the components of the test drug; (12)Subjects who are participating in other clinical trials, or have participated in other drug clinical trials within 1 month; (13)Subjects that are considered inappropriate to participate in this clinical trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s disease assessment scale-cognitive subscale(ADAS-Cog); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini Mental State Examination(MMSE);activities of daily living scale(ADL);clinician’s interview-based impression of change plus caregiver input scale(CIBIC-plus);neuropsychiatric inventory scale(NPI);Chinese medical syndrome scores; | — |
Countries
China
Contacts
Public ContactDan-tao Peng
China-Japan Friendship Hospital
Outcome results
None listed