PDR001 for Parkinson's (NCT07157345)
Clear harmful brain protein clumps
- Trial ID
- NCT07157345
- Official Title
- A Study on the Safety, Tolerability, and Efficacy of PDR-001 Injection for Bilateral Stereotactic Subthalamic Nucleus (STN) Clearance of α-synuclein
- Goal
- Clear harmful brain protein clumps
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Ruijin Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- PDR001
Summary For Families
The goal is to see if a new peptide treatment can remove harmful clumps of a protein called alpha-synuclein, which are thought to drive the nerve cell loss behind Parkinson's, with the hope of slowing or stopping disease progression. The peptide is packaged inside a viral shell and injected into a small deep brain area on both sides, the subthalamic nucleus; in animal studies this approach cleared alpha-synuclein and improved movement, and this first-in-human trial will test safety and look for early signs of benefit. The study plans to enroll about 12 people aged 40 to 65 with early, mild Parkinson's (diagnosed within the past 5 years and mild symptoms when off medication), who must pass cognitive and mood checks and have no prior brain surgery or certain medical or infection-related risks.
Locations
- Ruijin hospital, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying PDR001. The goal is to see if a new peptide treatment can remove harmful clumps of a protein called alpha-synuclein, which are thought to drive the nerve cell loss behind Parkinson's, with the hope of slowing or stopping disease progression. The peptide is packaged inside a viral shell and injected into a small deep brain area on both sides, the subthalamic nucleus; in animal studies this approach cleared alpha-synuclein and improved movement, and this first-in-human trial will test safety and look for early signs of benefit. The study plans to enroll about 12 people aged 40 to 65 with early, mild Parkinson's (diagnosed within the past 5 years and mild symptoms when off medication), who must pass cognitive and mood checks and have no prior brain surgery or certain medical or infection-related risks.
- Who can participate?
- Participants must be between 40 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 3 years and 3 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive). Confirm the full schedule with the study coordinator.