Parkinson Disease
Conditions
Keywords
Parkinson Disease, PET, UCB-J, PE2I, Positron Emission Tomography
Brief 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. 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.
Interventions
OTHER11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
OTHER18F-PE2I PET-CT
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.
DIAGNOSTIC_TESTMRI brain
Magnetic resonance imaging of brain volume.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participation in study S61477 (NCT04243304)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional correlation between clinical scores and SV2A at Year 7 | 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. |
| Cross-sectional SV2A at Year 7 | 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. |
| Longitudinal SV2A change between baseline and Year 7 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional DAT levels at Year 7 | Data analysis will be done when all subjects have undergone Year 7 evaluation. | Cross-sectional differences (%) in DAT levels at Year 7 between Parkinson disease patients and controls. |
| Longitudinal correlation between SV2A and DAT levels | Data analysis will be done when all subjects have undergone Year 7 evaluation. | Correlation between SV2A changes and DAT level changes in Parkinson disease patients. |
| Cross-sectional correlation between clinical scores and DAT levels at Year 7 | Data analysis will be done when all subjects have undergone Year 7 evaluation. | Cross-sectional correlation between clinical scores and DAT levels in Parkinson disease patients at Year 7. |
| Longitudinal DAT level change between baseline and Year 7 | Data analysis will be done when all subjects have undergone Year 7 evaluation. | Differences (%) in the rate of DAT level change between baseline and Year 7 between Parkinson disease patients and controls. |
| Longitudinal correlation between clinical scores and DAT levels | Data analysis will be done when all subjects have undergone Year 7 evaluation. | Correlation between progression of the clinical scores and longitudinal DAT level changes in Parkinson disease patients. |
Countries
Belgium
Contacts
Primary ContactWim Vandenberghe, MD, PhD
Backup ContactJolien Van Opstal, MD
Outcome results
None listed