Mild Vascular Cognitive Impairment
Conditions
Interventions
Treatment group:Bayer Aspirin combined with Ginkgo Ketone Ester Tablets
Control group:Bayer Aspirin
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for vascular cognitive impairment as outlined in the Diagnostic and Treatment Standards for Vascular Cognitive Impairment (2020 Edition). 2.Aged 45–85 years; sex unrestricted. 3.= 6 years of formal education and capable of completing cognitive assessments. 4.Mini-Mental State Examination (MMSE) scores: – Primary education: 20 2); 1–2 strategically located lacunes, or 1–2 non-strategic lacunes with extensive white-matter hyperintensities; (4) Extensive or confluent white-matter hyperintensities; (5) Any combination of the above. 6.Cognitive decline appeared after an ischemic stroke event and has persisted for at least 3–6 months. 7.ADL/IADL either unaffected or only mildly affected, without loss of independence. 8.Based on medical history, current health status, and comorbidities, the investigator judges the participant's stroke condition to be stable, with secondary cerebrovascular prevention in place and individualized antihypertensive, antidiabetic, or other relevant medications. 9.The participant must have a qualified informant or caregiver (in contact = 4 days per week) who is able to facilitate protocol compliance, accompany the participant to study visits, and provide reliable information for scales such as the NPI. 10.Willing to participate and has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Moderate-to-severe vascular dementia, Parkinson's disease, Alzheimer's disease, intracranial infection, traumatic brain injury, epilepsy, hypothyroidism, syphilis, or cognitive impairment attributable to folate or vitamin B12 deficiency, or any other identifiable cause. 2.History of intracerebral hemorrhage; hemorrhagic stroke in the acute phase; bleeding diathesis; or baseline CT/MRI evidence of intracranial hemorrhage or structural lesions predisposing to intracranial bleeding (e.g., intracerebral hematoma, subarachnoid hemorrhage, epidural hemorrhage, acute or chronic subdural hematoma). 3.Currently receiving Western medications for cognitive enhancement such as cholinesterase inhibitors or NMDA-receptor antagonists. 4.Severe neurological deficits precluding valid cognitive assessment, including clinically diagnosed blindness, aphasia, or other executive-function impairments. 5.Abnormal platelet or coagulation parameters: platelet count 3.0, or APTT > 100 s. 6.Concomitant severe cardiac, hepatic, pulmonary, renal, or hematopoietic disease, or active malignancy. 7.Life expectancy judged by the investigator, based on medical history, current health status, and comorbidities, to be = 6 months. 8.History of schizophrenia, bipolar disorder, or other major psychiatric illness. 9.Pregnant or lactating women. 10.Chronic alcohol abuse or misuse of psychoactive substances. 11.Known hypersensitivity to the investigational medication or its components, personal history of severe allergic reactions, or concurrent use of other Chinese herbal prescriptions or proprietary Chinese medicines. 12.Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment (MoCA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination (MMSE);Trail Making Test Part A (TMT-A);Trail Making Test Part B (TMT-B);Boston Naming Test – Second Edition (BNT-2);Hopkins Verbal Learning Test (HVLT);Clock Drawing Test (CDT);Activity of Daily Living Scale;the neuropsychiatric inventory;Self-rating Anxiety Scale (SAS);Geriatric Depression Scale (GDS-30);modified apathy evaluation scale; | — |
Countries
China
Contacts
Public Contactqing ye
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed