---
title: Brain injection clears sticky protein
nct_id: NCT07157345
phase: PHASE1
status: RECRUITING
sponsor: Ruijin Hospital
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07157345"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07157345"
last_fetched: "2026-05-10T14:04:29.116Z"
source: "Parkinson's Pathways (curated)"
---
# Brain injection clears sticky protein

**Goal (in five words):** Brain injection clears sticky protein

**Official Title:** A Study on the Safety, Tolerability, and Efficacy of PDR-001 Injection for Bilateral Stereotactic Subthalamic Nucleus (STN) Clearance of α-synuclein

**Trial ID:** [NCT07157345](https://clinicaltrials.gov/study/NCT07157345)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Ruijin Hospital
- **Target Enrollment:** 12 participants
- **Start Date:** 2025-10-20
- **Completion Date:** 2029-01-31
- **Conditions:** Parkinson Disease (PD)
- **Interventions:** PDR001
- **Intervention Types:** DRUG

## Summary For Families

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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 65 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

To be eligible for inclusion in this clinical study, all of the following criteria must be met:

1. 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);
2. Age 40-65 years (inclusive) at screening, either sex;
3. Disease duration ≤ 5 years;
4. Hoehn \& Yahr stage ≤ 2 in the "off" state.

Exclusion Criteria:

Exclusion Criteria

1. Atypical or secondary parkinsonian syndromes (e.g., Parkinson-plus syndromes, hereditary parkinsonism, drug-induced parkinsonism, etc.).
2. 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.
3. Previous neuroimaging revealing structural brain abnormalities, cerebral vascular malformations, intracranial tumors, risk of intracranial hemorrhage, traumatic brain injury, or other significant findings.
4. Mini-Mental State Examination (MMSE) score \< 24.
5. Patient Health Questionnaire-9 (PHQ-9) score ≥ 16.
6. 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.
7. Coagulation disorders or current use of anticoagulants.
8. 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.
9. Currently receiving antiviral therapy for hepatitis B or C.
```

## Locations (1)

- Ruijin hospital, Shanghai, Shanghai Municipality, China _(31.2222, 121.4581)_

## Central Contacts

- Yi Zhang — (CONTACT) — 64370045 — zy12893@rjh.com.cn

---

*Canonical: https://parkinsonspathways.com/trial/NCT07157345*  
*HTML version: https://parkinsonspathways.com/trial/NCT07157345*  
*Source data: https://clinicaltrials.gov/study/NCT07157345*