RecruitingRecruiting
Long-term Longitudinal Imaging of Presynaptic Terminals in PD
NCT06875765 · Universitaire Ziekenhuizen KU Leuven
In plain English
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Official title
Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 35 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-16
Estimated completion: 2027-12
Last updated: 2025-07-29
Interventions
Other: 11C-UCB-J PET-CTOther: 18F-PE2I PET-CTDiagnostic Test: MRI brain
Primary outcomes
- • Cross-sectional 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 at Year 7 (Data analysis will be done when all subjects have undergone Year 7 evaluation.)
- • Longitudinal SV2A change between baseline and Year 7 (Data analysis will be done when all subjects have undergone Year 7 evaluation.)
Sponsor
Universitaire Ziekenhuizen KU Leuven · other
Contacts & investigators
ContactWim Vandenberghe, MD, PhD · contact · wim.vandenberghe@uzleuven.be · +3216344280
ContactJolien Van Opstal, MD · contact · jolien.vanopstal@uzleuven.be · +3216338052
All locations (1)
UZ LeuvenRecruiting
Leuven, Belgium