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NCT06875765 | NOT YET RECRUITING | Parkinson Disease


Long-term Longitudinal Imaging of Presynaptic Terminals in PD
Sponsor:

University hospitals KU Leuven

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.

Condition or disease

Parkinson Disease

Intervention/treatment

11C-UCB-J PET-CT

18F-PE2I PET-CT

MRI brain

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 35 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

Long-term Longitudinal Imaging of Presynaptic Terminals in PD

Location Details

NCT06875765


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Locations


Not yet recruiting

Belgium,

UZ Leuven

Leuven, Belgium, 3000

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