Clinical Study of Chemogenetic Gene Therapy With AAV for Parkinson's Disease Using Stereotactic Surgery in the Subthalamic Nucleus

Korábbi kezelés

• Received other gene or cell therapy drugs;
• Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy;

Más betegség

• Has a past history of brain surgery for Parkinson's disease, such as deep brain stimulation, or other abnormal brain imaging findings;
• Has a history of brain injury or central nervous system infection;
• MoCA cognitive impairment score \< 26 points, and MMSE dementia rating scale cognitive impairment score ≤ 20 points;
• Evidence of major medical or mental illness, such as dementia, psychosis, history of drug abuse or severe depression;
• Atypical Parkinson's disease or secondary Parkinson's disease caused by factors such as trauma, brain tumor, infection, cerebrovascular disease, other neurological diseases or drugs, chemicals or toxins;
• Has a history of malignant tumors, but not including treated carcinoma in situ, or medical conditions that are poorly controlled and may increase the risk of surgery;
• Has a history of stroke, or obvious cardiovascular diseases, diabetes;
• Coagulation disorders or inability to temporarily stop any anticoagulant or antiplatelet treatment before surgery;

Laborértékek

• Clinically obvious or laboratory-detected infections;
• Severe liver disease (AST/ALT ≥ 2.5 times the upper limit of normal (ULN));

Egyéb

• Hamilton Depression Scale score ≥ 20;
• Hamilton Anxiety Scale score ≥ 14
• Focal neurological deficits;
• Any factor that may prevent the subject from following the study protocol, including medical or social factors, including geographical inconvenience;
• Any other situation that the investigator deems unsuitable for participation in this study.

• Age range: 40 - 70 years (inclusive), gender not restricted;
• Diagnosed with primary Parkinson's disease, with H\&Y grade ranging from 4 to 5;
• Disease duration of at least 5 years;
• Response to levodopa treatment lasting for at least 12 months;
• Score of the third part of the MDS-UPDRS Part III ≥ 35;
• Improvement rate of the Madopar challenge test ≥ 30%;
• Stable clinical symptoms and drug treatment for at least 4 weeks before screening;
• Capable of understanding and voluntarily signing the informed consent form;
• Participants agree to postpone any neurological surgery, including deep brain stimulation, until the completion of 12-month follow-up;
• The efficacy of dopamine drugs has significantly decreased, or there are obvious motor complications, or severe drug side effects;
• There are no acute adverse reactions to the prescribed olanzapine dose;
• Good compliance and willing to complete all the follow-up as stipulated in this protocol.