Long-term Longitudinal Imaging of Presynaptic Terminals in PD

NCT ID: NCT06875765

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Parkinson disease patients

Group Type EXPERIMENTAL

11C-UCB-J PET-CT

Intervention Type OTHER

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

18F-PE2I PET-CT

Intervention Type OTHER

Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.

MRI brain

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging of brain volume.

Healthy controls

Group Type ACTIVE_COMPARATOR

11C-UCB-J PET-CT

Intervention Type OTHER

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

18F-PE2I PET-CT

Intervention Type OTHER

Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.

MRI brain

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging of brain volume.

Interventions

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11C-UCB-J PET-CT

Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.

Intervention Type OTHER

18F-PE2I PET-CT

Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I.

Intervention Type OTHER

MRI brain

Magnetic resonance imaging of brain volume.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Wim Vandenberghe, MD, PhD

Role: CONTACT

+3216344280

Jolien Van Opstal, MD

Role: CONTACT

+3216338052

Facility Contacts

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Jolien Van Opstal, MD

Role: primary

+16338052

References

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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.

Reference Type BACKGROUND
PMID: 32767618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35819412 (View on PubMed)

Other Identifiers

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S69680

Identifier Type: -

Identifier Source: org_study_id

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