Idiopathic Parkinson DiseasePDNCT07919262
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
An observational study of Idiopathic Parkinson Disease, run by Xuanwu Hospital, Beijing.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- Brain PET Examination and Clinical assessment, blood sampling and brain PET examination
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- Brain PET Examination, Clinical assessment, blood sampling and brain PET examination
- Keywords
- 18F-DOPA PET, Parkinson's disease, moderate to advanced Parkinson disease, biomarker
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain PET ExaminationDiagnostic test
idiopathic Parkinson's disease
Clinical assessment, blood sampling and brain PET examinationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Parkinson's Disease Cohort | 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. Receives: Diagnostic Test: Brain PET Examination; Diagnostic Test: Clinical assessment, blood sampling and brain PET examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months after enrollment
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xucuiping, Xuanwu Hospital, Beijing
- Investigators
- Cuiping Xu, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919262
- Sponsor's protocol ID
- KS2026241
- Acronym
- PD
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With participant consent, the data from this study will be shared and compared with other therapeutic approaches for Parkinson's disease.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07919262
- Acronym / sponsor ID
- PD / KS2026241
- Conditions
- Idiopathic Parkinson Disease
- Keywords
- 18F-DOPA PET, Parkinson's disease, moderate to advanced Parkinson disease, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's Disease Cohort | – | Diagnostic Test: Brain PET Examination, Diagnostic Test: Clinical assessment, blood sampling and brain PET examinationPatients 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain PET Examinationidiopathic Parkinson's disease | Diagnostic test | Idiopathic Parkinson's Disease Cohort |
| Clinical assessment, blood sampling and brain PET examinationPeripheral 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. | Diagnostic test | Idiopathic Parkinson's Disease Cohort |
Primary outcome
Change in Putamen 18F-DOPA PET Specific Binding Ratio (SBR) from Baseline to 12 Months
Time frame: Baseline and 12 months after enrollment
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.
2 secondary outcomes
Change in MDS-UPDRS Part III Score from Baseline to 12 Months
Time frame: Baseline and 12 months after enrollment
Change in Hoehn-Yahr Stage from Baseline to 12 Months
Time frame: Baseline and 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. With participant consent, the data from this study will be shared and compared with other therapeutic approaches for Parkinson's disease.
Related trials for Idiopathic Parkinson Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cuiping Xu principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinson Disease, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuiping Xu, MD (+86-131-2668-5830, mestory@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Putamen 18F-DOPA PET Specific Binding Ratio (SBR) from Baseline to 12 Months (time frame: Baseline and 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.