Study on the influence of the key gene phenotype and the effect of qi-supplementing and blood-activating therapy on the therapeutic effect of statins in vascular dementia

Not Applicable

• Conditions: Vascular Dementia

• Registration Number: ITMCTR2100005177
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 <= 17;
7. TCM syndrome differentiation is Qi deficiency and blood stasis syndrome, and the syndrome score is >=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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini-mental State Examination (MMSE);Blood lipid level;

Secondary Outcome Measures

Name	Time	Method
Blood concentration of statins and metabolites/n;The ApoE gene test;Analysis of endogenous metabolites;Syndrome score of traditional Chinese medicine;