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NCT07919262Not yet recruiting

Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers

Quantitative Longitudinal Observation of Neurodegeneration in Patients With Moderate to Advanced Primary Parkinson's Disease Using ¹⁸F-DOPA PET-CT Molecular Imaging and Blood Biomarkers

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
36 (estimated)
First submitted
25 Oct 2026
Start date
Nov 2026
Primary completion date
Apr 2028
Lead sponsor
Xuanwu Hospital, Beijing
NCT number
NCT07919262

What you commit to

  • Study type: Observational
  • Planned participants: 36
  • From Nov 2026 to the primary completion date, Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior surgical treatment for Parkinson's disease;

Other illness

  • Secondary parkinsonism / atypical parkinsonian syndromes;
  • Genetically confirmed 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.

Who the study is looking for

  • 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.

Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.