Ischemic mild vascular cognitive impairment
Conditions
Interventions
Low-dose experimental group of ginkgo biloba extract 50 tablets:On the basis of conventional treatment, add Ginkgo biloba extract 50 mimic tablet + Ginkgo biloba extract 50 tablet, 1 tablet of Ginkgo
High-dose experimental group of ginkgo biloba extract 50 tablets:On the basis of conventional treatment, add Ginkgo biloba extract 50 tablets, 2 tablets each time, 3 times a day
Placebo control group:On the basis of conventional treatment, add ginkgo biloba extract 50 mimetic tablets, 2 tablets each time, 3 times a day
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 50-85 years, no gender limit. 2. Meet the diagnostic criteria for mild vascular cognitive impairment (mVCI) of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Degree of illness: primary school education, 21=4 points. 5. Memory loss for at least 6 months. 6. Head MRI plain scan within 3 months during screening meets any of the following criteria: (1) One or more large vascular infarction; (2) One or more key position infarction; (3) Multiple lacunar infarcts outside the brainstem (>2) or 1-2 critical Spaces with extensive white matter lesions; (4) Extensive fusion of white matter lesions; (5) The combination of above. The Visual Rating Scale of medial temporal atrophy (MTA) was lower than level 2. 7. At least 5 years of education and the ability to complete the cognitive tests and other tests prescribed by the program. 8. The women were postmenopausal (>=24 weeks postmenopausal), underwent surgical sterilization, or consented to effective contraceptive use during the trial. Women of childbearing age or those who have gone through menopause at less than 24 weeks must undergo a urine test at the time of screening, which must be negative. 9. Patients should have qualified informants and caregivers, or at least frequent contact with them (at least 4 days a week, at least 2 hours a day), who will assist patients in the whole study process. The informants and caregivers must understand the patient's condition, accompany the patients to participate in the study visit, and have sufficient interaction and communication with the patients in order to provide valuable information for NPI, CGI and other scales. 10. Patients must sign a written informed consent prior to performing procedures or examinations related to the program. 11. Before enrollment, if the patient is taking a drug similar to the test drug, the medication should be stopped to ensure that the evaluation of the test results will not be affected. If the medication could not be stopped, the enrolled dose was maintained.
Exclusion criteria
Exclusion criteria: 1. Unstable or severe heart, lung, liver, kidney, hematopoietic system diseases (including unstable angina, myocardial infarction, uncontrolled asthma, active gastric bleeding, cancer, mechanical ileus, bone marrow transplantation history, etc.). 2. For patients with acute active stage of cerebral hemorrhage and bleeding tendency, baseline CT or MRI scan shows signs of intracranial hemorrhage or other structural damage that may lead to increased risk of intracranial hemorrhage (intracranial hematoma, subarachnoid hemorrhage, epidural blood, acute or chronic subdural hematoma). Patients with abnormal platelet and coagulation function (platelet count 3.0, APTT > 100 s. 3. There is alcohol or drug abuse. 4. Known allergy to the components of this medicine. 5. Patients enrolled in clinical trials of other drugs within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trail making test;Boston Naming Test 2nd Edition;Hopkins Language Learning Test;Clock drawing test;Mini-mental State Examination;Cranial MRI; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Clinical Global Impression Scale for clinician interviews;Instrumental Daily Living Ability Assessment Scale;Neuropsychiatric Behavioral Questionnaire - Clinician Rating Scale; | — |
Countries
China
Contacts
Public ContactLi Xia
Shanghai Mental Health Center
Outcome results
None listed