Parkinson's disease
Conditions
Interventions
Low titer group:Intracerebral injection of 1×10^12 VG/mL AAV2/9-hSyn-hM4Di injection solution into the bilateral subthalamic nuclei
High titer group:Intracerebral injection of 3×10^12 VG/mL AAV2/9-hSyn-hM4Di injection solution into the bilateral subthalamic nuclei
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 40 - 70 years (inclusive), gender not restricted; 2.Diagnosed with primary Parkinson's disease, with H&Y grade ranging from 4 to 5; 3.Disease duration of at least 5 years; 4.Response to levodopa treatment lasting for at least 12 months; 5.Score of the third part of the MDS Parkinson's Disease Rating Scale (MDS-UPDRS Part III) >= 35; 6.Improvement rate of the Madopar challenge test >= 30%; 7.Stable clinical symptoms and drug treatment for at least 4 weeks before screening; 8.Capable of understanding and voluntarily signing the informed consent form; 9.Participants agree to postpone any neurological surgery, including deep brain stimulation, until the completion of 12-month follow-up; 10.The efficacy of dopamine drugs has significantly decreased, or there are obvious motor complications, or severe drug side effects; 11.There are no acute adverse reactions to the prescribed olanzapine dose; 12.Good compliance and willing to complete all the follow-up as stipulated in this protocol.
Exclusion criteria
Exclusion criteria: 1.Has a past history of brain surgery for Parkinson's disease, such as deep brain stimulation, or other abnormal brain imaging findings; 2.Hamilton Depression Scale score >= 20; 3.Hamilton Anxiety Scale score >= 14; 4.Has a history of brain injury or central nervous system infection; 5.MoCA cognitive impairment score = 2.5 times the upper limit of normal (ULN)); 16.Any factor that may prevent the subject from following the study protocol, including medical or social factors, including geographical inconvenience; 17.Any other situation that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse events related to the STP-001 injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness indicators of the STP-001 injection;The incidence rate of adverse events of the STP-001 injection; | — |
Countries
China
Contacts
Public ContactPu Jiali
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed