Parkinson DiseaseNCT06875765
Long-term Longitudinal Imaging of Presynaptic Terminals in PD
A study testing 11C-UCB-J PET-CT, 18F-PE2I PET-CT and MRI brain in people with Parkinson Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
AIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 11C-UCB-J PET-CT, 18F-PE2I PET-CT and MRI brain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jul 2025to Dec 2027
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation in study S61477 (NCT04243304)
Who cannot join
- Neuropsychiatric diseases (unrelated to PD for PD patients)
- Major internal medical diseases
- History of alcohol or drug abuse
- Relevant abnormalities on MR brain
- Contraindications for MR
- Pregnancy or breastfeeding
- Previous participation in other research studies involving ionizing radiation with > 1 mSv over past 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Jolien Van Opstal, MD, +16338052, jolien.vanopstal@uzleuven.be
Wim Vandenberghe, MD, PhD
About this study
Official title: Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
AIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD.
STUDY DESIGN: The investigators will re-invite participants (both patients with PD and healthy controls) of a previous longitudinal study (NCT04243304, S61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). All participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11C-UCB-J PET-CT (targeting synaptic density marker SV2A), 18F-FE-PE2I PET-CT (targeting DAT) and brain MRI.
- Conditions
- Parkinson Disease
- Being tested
- 11C-UCB-J PET-CT, 18F-PE2I PET-CT, MRI brain
- Keywords
- Parkinson Disease, PET, UCB-J, PE2I, Positron Emission Tomography
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-UCB-J PET-CTOther
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
18F-PE2I PET-CTOther
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.
MRI brainDiagnostic test
Magnetic resonance imaging of brain volume.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease patients | Experimental | Not described Receives: Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-CT; Diagnostic Test: MRI brain |
| Healthy controls | Active comparator | Not described Receives: Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-CT; Diagnostic Test: MRI brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional SV2A at Year 7
Cross-sectional differences (%) in SV2A signal at Year 7 between Parkinson disease patients and controls.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and SV2A at Year 7
Cross-sectional correlation between clinical scores and SV2A in Parkinson disease patients at Year 7.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal SV2A change between baseline and Year 7
Differences (%) in the rate of SV2A change between baseline and Year 7 between Parkinson disease patients and controls.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between clinical scores and SV2A
Correlation between progression of the clinical scores and longitudinal SV2A changes in Parkinson disease patients.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Secondary outcomes (5)
Cross-sectional DAT levels at Year 7
Cross-sectional differences (%) in DAT levels at Year 7 between Parkinson disease patients and controls.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and DAT levels at Year 7
Cross-sectional correlation between clinical scores and DAT levels in Parkinson disease patients at Year 7.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal DAT level change between baseline and Year 7
Differences (%) in the rate of DAT level change between baseline and Year 7 between Parkinson disease patients and controls.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between clinical scores and DAT levels
Correlation between progression of the clinical scores and longitudinal DAT level changes in Parkinson disease patients.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between SV2A and DAT levels
Correlation between SV2A changes and DAT level changes in Parkinson disease patients.
Measured: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start16 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal study design (total follow up time of 7 years) where longitudinal changes of SV2A PET, PE2I PET and clinical rating scales will be compared between patients with PD and healthy controls.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875765
- Sponsor's protocol ID
- S69680
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delva A, Van Weehaeghe D, Koole M, Van Laere K, Vandenberghe W. Loss of Presynaptic Terminal Integrity in the Substantia Nigra in Early Parkinson's Disease. Mov Disord. 2020 Nov;35(11):1977-1986. doi: 10.1002/mds.28216. Epub 2020 Aug 7.
PubMed 32767618Delva A, Van Laere K, Vandenberghe W. Longitudinal Positron Emission Tomography Imaging of Presynaptic Terminals in Early Parkinson's Disease. Mov Disord. 2022 Sep;37(9):1883-1892. doi: 10.1002/mds.29148. Epub 2022 Jul 12.
PubMed 35819412
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06875765
- Acronym / sponsor ID
- S69680
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, PET, UCB-J, PE2I, Positron Emission Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Mar 2025 (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.
AIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD.
STUDY DESIGN: The investigators will re-invite participants (both patients with PD and healthy controls) of a previous longitudinal study (NCT04243304, S61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). All participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11C-UCB-J PET-CT (targeting synaptic density marker SV2A), 18F-FE-PE2I PET-CT (targeting DAT) and brain MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal study design (total follow up time of 7 years) where longitudinal changes of SV2A PET, PE2I PET and clinical rating scales will be compared between patients with PD and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease patients | Experimental | Other: 11C-UCB-J PET-CT, Other: 18F-PE2I PET-CT, Diagnostic Test: MRI brain |
| Healthy controls | Active comparator | Other: 11C-UCB-J PET-CT, Other: 18F-PE2I PET-CT, Diagnostic Test: MRI brain |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in study S61477 (NCT04243304)
Key exclusion criteria (7 listed)
- Neuropsychiatric diseases (unrelated to PD for PD patients)
- Major internal medical diseases
- History of alcohol or drug abuse
- Relevant abnormalities on MR brain
- Contraindications for MR
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 |
|---|---|---|
| 11C-UCB-J PET-CTPositron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J. | Other | Healthy controls, Parkinson disease patients |
| 18F-PE2I PET-CTPositron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I. | Other | Healthy controls, Parkinson disease patients |
| MRI brainMagnetic resonance imaging of brain volume. | Diagnostic test | Healthy controls, Parkinson disease patients |
Primary outcome
Cross-sectional SV2A at Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional differences (%) in SV2A signal at Year 7 between Parkinson disease patients and controls.
Cross-sectional correlation between clinical scores and SV2A at Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and SV2A in Parkinson disease patients at Year 7.
Longitudinal SV2A change between baseline and Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Differences (%) in the rate of SV2A change between baseline and Year 7 between Parkinson disease patients and controls.
Longitudinal correlation between clinical scores and SV2A
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Correlation between progression of the clinical scores and longitudinal SV2A changes in Parkinson disease patients.
5 secondary outcomes
Cross-sectional DAT levels at Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and DAT levels at Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal DAT level change between baseline and Year 7
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between clinical scores and DAT levels
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Longitudinal correlation between SV2A and DAT levels
Time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
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 29 Jul 2025.
- Background: PubMed 32767618Delva A, Van Weehaeghe D, Koole M, Van Laere K, Vandenberghe W. Loss of Presynaptic Terminal Integrity in the Substantia Nigra in Early Parkinson's Disease. Mov Disord. 2020 Nov;35(11):1977-1986. doi: 10.1002/mds.28216. Epub 2020 Aug 7.
- Background: PubMed 35819412Delva A, Van Laere K, Vandenberghe W. Longitudinal Positron Emission Tomography Imaging of Presynaptic Terminals in Early Parkinson's Disease. Mov Disord. 2022 Sep;37(9):1883-1892. doi: 10.1002/mds.29148. Epub 2022 Jul 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-UCB-J PET-CT, 18F-PE2I PET-CT and MRI brain in people with Parkinson Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Wim Vandenberghe, MD, PhD (+3216344280, wim.vandenberghe@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional SV2A at Year 7 (time frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875765, which also lists 2 linked publications.
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 29 Jul 2025.