Status:
RECRUITING
Testing if PDR-001 Can Safely and Effectively Remove Harmful Brain Protein in Parkinson's Disease
Lead Sponsor:
Ruijin Hospital
Conditions:
Parkinson Disease (PD)
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief Summary
Parkinson's disease (PD) poses a severe threat to human health, and its incidence is rising year by year. Current therapeutic options are limited by significant shortcomings. Pathological aggregation ...
Eligibility Criteria
Inclusion
- To be eligible for inclusion in this clinical study, all of the following criteria must be met:
- Clinically confirmed diagnosis of primary PD (in accordance with the 2016 Chinese Diagnostic Criteria for Parkinson's Disease or the 2015 MDS Clinical Diagnostic Criteria for primary PD);
- Age 40-65 years (inclusive) at screening, either sex;
- Disease duration ≤ 5 years;
- Hoehn \& Yahr stage ≤ 2 in the "off" state.
Exclusion
- Exclusion Criteria
- Atypical or secondary parkinsonian syndromes (e.g., Parkinson-plus syndromes, hereditary parkinsonism, drug-induced parkinsonism, etc.).
- Contra-indications to surgery, or any prior intracranial procedure such as deep-brain stimulation, pallidotomy, or other extrapyramidal surgery, or any other neurosurgical intervention deemed by the investigator to interfere with study participation.
- Previous neuroimaging revealing structural brain abnormalities, cerebral vascular malformations, intracranial tumors, risk of intracranial hemorrhage, traumatic brain injury, or other significant findings.
- Mini-Mental State Examination (MMSE) score \< 24.
- Patient Health Questionnaire-9 (PHQ-9) score ≥ 16.
- Abnormal hepatic or renal function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN), or serum creatinine (Cr) \> 1.5 × ULN.
- Coagulation disorders or current use of anticoagulants.
- Positive screening for infectious diseases:
- Hepatitis B surface antigen (HBsAg) or Hepatitis B virus DNA (HBV-DNA) positive;
- Hepatitis C virus RNA (HCV-RNA) positive;
- Human immunodeficiency virus (HIV) positive;
- Positive syphilis serology.
- Currently receiving antiviral therapy for hepatitis B or C.
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07157345
Start Date
October 20 2025
End Date
December 31 2029
Last Update
September 5 2025
Active Locations (1)
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1
Ruijin hospital
Shanghai, Shanghai Municipality, China, 200000