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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson disease patients | Experimental |
| |
| Healthy controls | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-UCB-J PET-CT | Other | Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional SV2A at Year 7 | Cross-sectional differences (%) in SV2A signal at Year 7 between Parkinson disease patients and controls. | 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. | 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. | 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. | Data analysis will be done when all subjects have undergone Year 7 evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional DAT levels at Year 7 | Cross-sectional differences (%) in DAT levels at Year 7 between Parkinson disease patients and controls. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wim Vandenberghe, MD, PhD | Contact | +3216344280 | wim.vandenberghe@uzleuven.be | |
| Jolien Van Opstal, MD | Contact | +3216338052 | jolien.vanopstal@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32767618 | Background | 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. | |
| 35819412 | Background | Delva 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| 18F-PE2I PET-CT | Other | Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I. |
|
| MRI brain | Diagnostic Test | Magnetic resonance imaging of brain volume. |
|
Cross-sectional correlation between clinical scores and DAT levels in Parkinson disease patients at Year 7. |
| 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. | 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. | 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. | Data analysis will be done when all subjects have undergone Year 7 evaluation. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |