Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Differences in the rate of decline of synaptic density.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Differences in the rate of decline of synaptic density.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline differences (%) in synaptic density between patients and controls.
Secondary Outcomes
- 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.)
- Baseline differences in DAT levels.(Data analysis wel be done when all subjects have undergone the baseline evaluation.)
- 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 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.)