Brain injection clears sticky protein
- 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
- Brain injection clears sticky protein
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Ruijin Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- PDR001
Plain-Language Summary
The goal is to see if injecting PDR-001 directly into both subthalamic nuclei can safely reduce aggregated alpha-synuclein, the sticky protein linked to neuron damage in Parkinson's, and to look for early signs that clearing it might help symptoms or slow progression. The approach is a stereotactic neurosurgical injection of PDR-001 into the STN to target and promote removal of misfolded alpha-synuclein; it is not a dopamine replacement like levodopa, so it would be given alongside standard Parkinson's medications rather than replacing them. Eligible participants are adults 40 to 65 years old with early PD diagnosed within the past 5 years and Hoehn and Yahr stage 2 or less in the off state. People with prior brain surgery, significant cognitive impairment or depression, clotting problems, abnormal liver or kidney tests, or active viral infections are excluded.
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 injecting PDR-001 directly into both subthalamic nuclei can safely reduce aggregated alpha-synuclein, the sticky protein linked to neuron damage in Parkinson's, and to look for early signs that clearing it might help symptoms or slow progression. The approach is a stereotactic neurosurgical injection of PDR-001 into the STN to target and promote removal of misfolded alpha-synuclein; it is not a dopamine replacement like levodopa, so it would be given alongside standard Parkinson's medications rather than replacing them. Eligible participants are adults 40 to 65 years old with early PD diagnosed within the past 5 years and Hoehn and Yahr stage 2 or less in the off state. People with prior brain surgery, significant cognitive impairment or depression, clotting problems, abnormal liver or kidney tests, or active viral infections are excluded.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 3 years and 3 months.