Synaptic Density and Progression of Parkinson's Disease.
- Conditions
- Parkinson Disease
- Interventions
- Other: 11C-UCB-J PET-CTOther: 18F-PE2I PET-MR
- Registration Number
- NCT04243304
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease
- 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
- Neuropsychiatric diseases other than PD
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD patients 11C-UCB-J PET-CT At baseline and 2-year follow-up Healthy controls 11C-UCB-J PET-CT At baseline and 2-year follow-up Healthy controls 18F-PE2I PET-MR At baseline and 2-year follow-up PD patients 18F-PE2I PET-MR At baseline and 2-year follow-up
- Primary Outcome Measures
Name Time Method Differences in the rate of decline of synaptic density. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Differences (%) in the rate of decline of synaptic density between patients and controls.
Correlations between clinical scores and synaptic density. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Correlations between clinical scores and synaptic density in the patient group.
Correlations between progression of the clinical scores and decline of synaptic density. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
Baseline differences in synaptic density. Data analysis wel be done when all subjects have undergone the baseline evaluation. Baseline differences (%) in synaptic density between patients and controls.
- Secondary Outcome Measures
Name Time Method Differences in the rate of decline of global and DAT levels. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Differences (%) in the rate of decline of global and DAT levels between patients and controls.
Baseline differences in DAT levels. Data analysis wel be done when all subjects have undergone the baseline evaluation. Baseline differences (%) in DAT levels between patients and controls.
Correlations between clinical scores and DAT levels. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Correlations between clinical scores and DAT levels in the patient group.
Correlations between progression of the clinical scores and decline of DAT levels. Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation. Correlations between progression of the clinical scores and decline of DAT levels in the patient group.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium