Parkinson Disease
Conditions
Keywords
Parkinson Disease, PET, UCB-J, PE2I
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.
Interventions
OTHER11C-UCB-J PET-CT
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
OTHER18F-PE2I PET-MR
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Belgium
Outcome results
None listed