Brain surgery and gene therapy aim to tame Parkinson's symptoms
NCT ID NCT07533591
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new gene therapy for Parkinson's disease. Six participants will receive a virus-based treatment injected into a specific brain area during surgery. Afterward, they take a drug to control abnormal brain activity and improve movement. The main goal is to check safety, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STP-001 (gene therapy with AAV vector and clozapine)
- What this could lead to
- If it works, this could point toward a new way to control Parkinson's motor symptoms without long-term medication side effects.
- What could go wrong
- This is a very early, small trial (6 people) focused on safety, not proof of effectiveness. The approach is experimental and may not work or could cause side effects like brain inflammation or movement problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Has a past history of brain surgery for Parkinson's disease, such as deep brain stimulation, or other abnormal brain imaging findings; * Hamilton Depression Scale score ≥ 20; * Hamilton Anxiety Scale score ≥ 14 * 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; * Focal neurological deficits; * 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; * Received other gene or cell therapy drugs; * 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; * Clinically obvious or laboratory-detected infections; * Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy; * Coagulation disorders or inability to temporarily stop any anticoagulant or antiplatelet treatment before surgery; * Severe liver disease (AST/ALT ≥ 2.5 times the upper limit of normal (ULN)); * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine,Zhejiang University
Zhejiang, Province, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a gentle brain zapping schedule ease Parkinson's symptoms?