Clinical trial NCT06875765: Long-term Longitudinal Imaging of Presynaptic Terminals in PD
Official title: Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
PET
UCB-J
PE2I
Positron Emission Tomography
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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: We 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.

Primary outcomes:
measure: Cross-sectional SV2A at Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Cross-sectional correlation between clinical scores and SV2A at Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Longitudinal SV2A change between baseline and Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Longitudinal correlation between clinical scores and SV2A
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Secondary outcomes:
measure: Cross-sectional DAT levels at Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Cross-sectional correlation between clinical scores and DAT levels at Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Longitudinal DAT level change between baseline and Year 7
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Longitudinal correlation between clinical scores and DAT levels
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
measure: Longitudinal correlation between SV2A and DAT levels
timeFrame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
citation: 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.
citation: 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.