Synaptic Density and Progression of Parkinson's Disease.
NCT ID: NCT04243304
Last Updated: 2022-05-19
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-10-01
2022-02-28
Brief Summary
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DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PD patients
At baseline and 2-year follow-up
11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
18F-PE2I PET-MR
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
Healthy controls
At baseline and 2-year follow-up
11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
18F-PE2I PET-MR
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
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.
18F-PE2I PET-MR
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
Eligibility Criteria
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Inclusion Criteria
* Less than 5 years disease duration since motor symptom onset according to the patient
* Hoehn-Yahr stage 1 or 2 in medication ON state
* Capacity to understand the informed consent form
Exclusion Criteria
* Major internal medical diseases
* Relevant abnormalities on MR brain
* History of alcohol or drug abuse
* Contraindications for MR
* Pregnancy
* Previous participation in other research studies involving ionizing radiation with \> 1 mSv over past 12 months.
30 Years
80 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Wim Vandenberghe, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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s61477
Identifier Type: -
Identifier Source: org_study_id
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