An observational study in Idiopathic Parkinson Disease, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Xuanwu Hospital, Beijing · Observational
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.
Primary Parkinson's disease (PD) is the second-most common neurodegenerative disease. Current clinical assessments rely heavily on motor-based rating scales, lacking quantitative biomarkers for dynamic evaluation of nigrostriatal neurodegeneration. Existing large PD cohorts focus mostly on early-stage patients, while longitudinal evidence combining ¹⁸F-DOPA PET molecular imaging and circulating blood biomarkers for moderate-to-advanced PD remains limited. This single-center, prospective observational cohort study is performed at Xuanwu Hospital, Capital Medical University. Thirty-six participants with moderate-to-advanced PD (Hoehn-Yahr stage 3-4) will be enrolled. The study schedule includes baseline assessments and repeated follow-up evaluations at 6-, and 12-months after enrollment. Study-related procedures cover clinical rating scales, physical and laboratory examinations, levodopa challenge test, ¹⁸F-DOPA PET-CT scans, blood sample collection and PD-related genetic testing. Adverse events and concomitant medications are collected throughout the study period. Early-withdrawn participants will complete required safety assessments. Potential risks are mainly associated with PET-CT radiation exposure and gastrointestinal side-effects of carbidopa. All participants will receive standardized medication counseling for PD during follow-up. Part of imaging and genetic testing will be completed by collaborative institutions. Conducted in accordance with the Declaration of Helsinki, the study requires written informed consent prior to any study-related procedures. Subjects may withdraw freely at any time without impact on routine medical care. This work aims to develop an integrated imaging-blood biomarker model to quantify PD-related neurodegeneration and explore potential surrogate endpoints for future disease-modifying trials. Both positive and negative findings will be publicly reported.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 36 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Parkinson's disease from the outpatient department of Xuanwu Hospital, Capital Medical University, Beijing, who meet the inclusion and exclusion criteria of this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with moderate to advanced idiopathic Parkinson's disease who will undergo clinical assessments, blood sample collection, and brain PET examinations, with longitudinal follow-up for 1 year.
Diagnostic Test: Brain PET Examination · Diagnostic Test: Clinical assessment, blood sampling and brain PET examination
idiopathic Parkinson's disease
Peripheral blood samples will be collected at baseline, 6 and 12 months for Parkinson's disease-related genetic testing and measurement of blood biomarkers including neurofilament light chain, α-synuclein, glial fibrillary acidic protein, Tau protein and inflammatory factors.
Change in Putamen 18F-DOPA PET Specific Binding Ratio (SBR) from Baseline to 12 Months
Change in 18F-DOPA PET specific binding ratio (SBR) in the putamen from baseline to 12 months after enrollment. SBR is calculated as the ratio of radiotracer uptake in the putamen to that in a reference region. Higher SBR values indicate greater presynaptic dopaminergic function.
Time frame: Baseline and 12 months after enrollment
Change in MDS-UPDRS Part III Score from Baseline to 12 Months
Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score from baseline to 12 months after enrollment. MDS-UPDRS Part III is a clinician-rated motor examination composed of 18 items yielding 33 individual ratings. Each rating is scored from 0 to 4 (0 = normal, 4 = severe).
Time frame: Baseline and 12 months after enrollment
Change in Hoehn-Yahr Stage from Baseline to 12 Months
This study enrolls patients with Hoehn-Yahr stage 3 to 4. Higher stages indicate more advanced disease.
Time frame: Baseline and 12 months after enrollment
No study locations are listed for this record.
Plan to share: Yes — With participant consent, the data from this study will be shared and compared with other therapeutic approaches for Parkinson's disease.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 17 months is below that.
Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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