Vascular Dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects with vascular dementia: 1. Aged 40 to 80 years, gender is not limited; 2. More than 6 years of education (including 6 years); 3. Meet the diagnostic criteria for vascular dementia, and the course of dementia lasts for more than 6 months; 4. Patients with mild or moderate disease, with a score between 10 and 24 on the Mini-Mental State Examination (MMSE); 5. Patients who meet the indications for statin use and are currently taking statin therapy or have not taken statin; 6. Modified Hachinski Ischemia Scale (mHIS) total score >= 4; Hamilton Depression Scale (HAMD) total score =7 points; 8. The subjects voluntarily participate in the clinical trial, and they and their agents sign the informed consent form before the trial. Inclusion criteria for healthy subjects: 1. Aged 25 to 80 years, no gender limitation; 2. No previous or current history of severe cardiovascular and cerebrovascular diseases, stroke and other neurological diseases; 3. No obvious cognitive impairment, depression, anxiety, etc., and no serious mental system diseases; 4. Have not taken any drugs in the past 3 months, and laboratory test indicators such as blood lipids, liver and kidney function, and coagulation function are normal/abnormal but have no clinical significance; 5. Those who volunteered to participate in clinical trials and signed the informed consent.
Exclusion criteria
Exclusion criteria: Vascular dementia subjects: 1. Dementia caused by brain diseases other than vascular dementia, such as Parkinson's disease, central nervous system demyelinating disease, tumor, hydrocephalus, trauma, central system infection such as syphilis, AIDS, Creutzfeldt-Jakob disease, etc.; 2. Those with severe neurological deficits who cannot complete the examination, such as audio-visual impairment; 3. Severe circulatory, respiratory, urinary and hematopoietic diseases, such as uncontrolled asthma, etc.; 4. Serious mental illness, such as schizophrenia and epilepsy; 5. Alcohol and drug abuse; 6. Those who are allergic to the drug ingredients used in the research; 7. Participated in other clinical trials within 3 months before the start of this study. Healthy subjects: 1. Abnormal laboratory indicators: Hb and Plt are less than the lower limit of normal; APTT exceeds the normal control value for more than 10 seconds, PT exceeds the normal control value for more than 3 seconds; Scr exceeds the upper limit of the normal value; ALT, AST, ALP, ?-GT, TBIL 1.5 times the upper limit of normal; 2. Severe circulatory, respiratory, urinary, digestive, hematopoietic system diseases (such as unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and cancer; 3. Serious mental illness, such as schizophrenia and epilepsy; 4. Alcohol and drug abuse; 5. Participated in other clinical trials within 3 months before the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-mental State Examination (MMSE);Blood lipid level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentration of statins and metabolites/n;The ApoE gene test;Analysis of endogenous metabolites;Syndrome score of traditional Chinese medicine; | — |
Countries
China
Contacts
Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine