Long-term Longitudinal Imaging of Presynaptic Terminals in PD

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: 18F-PE2I PET-CT; Diagnostic Test: MRI brain; Other: 11C-UCB-J PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06875765

S69680

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Parkinson disease patients

Experimental group

Treatment:

Other: 11C-UCB-J PET-CT

Diagnostic Test: MRI brain

Other: 18F-PE2I PET-CT

Healthy controls

Active Comparator group

Treatment:

Other: 11C-UCB-J PET-CT

Diagnostic Test: MRI brain

Other: 18F-PE2I PET-CT