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NCT07919262
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Conditions: Idiopathic Parkinson Disease
Sex: All
Ages: 21 Years – 75 Years
Healthy volunteers: No
Enrollment: 36
Sponsor: Xuanwu Hospital, Beijing
Summary
This is a single-center, prospective observational study of patients with moderate-to-advanced primary Parkinson's disease (PD). PD is the second most common neurodegenerative disease. Current clinical evaluation mainly depends on motor symptoms, and there is a lack of quantitative biomarkers that can dynamically show nigrostriatal neurodegeneration.
This study aims to explore the changing pattern of neurodegeneration by combining ¹⁸F-DOPA PET imaging and blood biomarkers such as neurofilament light chain, alpha-synuclein, GFAP, Tau and inflammatory factors. Thirty-six eligible participants will be enrolled. At baseline, clinical scales, lab tests, blood collection and ¹⁸F-DOPA PET-CT will be performed. Follow-up assessments will take place at 6 and 12 months.
The primary outcome is the change in ¹⁸F-DOPA PET measurements from baseline to 12 months. Secondary outcomes include changes in clinical rating scales and blood biomarkers over 1 year. Participants can receive standardized medication advice for PD during the study.
Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of primary Parkinson's disease;
* Age 21 to 75 years, no sex restriction;
* Hoehn-Yahr (H\&Y) stage 3-4;
* OFF-state MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor score \> 33, with a positive Madopar challenge test (MDS-UPDRS-III improvement rate \> 30%);
* Willingness to participate in the study and signed informed consent form.
Exclusion Criteria:
* Secondary parkinsonism / atypical parkinsonian syndromes;
* Genetically confirmed Parkinson's disease;
* Prior surgical treatment for Parkinson's disease;
* Contraindications to ¹⁸F-DOPA PET-CT scanning, including but not limited to cardiac pacemakers/defibrillators, ferromagnetic metallic implants (excluding skull-based and cardiac devices with MRI safety approval);
* Comorbid dementia, severe cognitive impairment, or severe psychiatric disorders.
Source: ClinicalTrials.gov (NCT07919262). StuddyBuddy aggregates publicly available trial information.