Longitudinal Measurement of Synaptic Loss and Cognitive Decline in the Long-term Course of Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Cross-sectional SV2A at Year 7
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Parkinson disease patients
Intervention: 11C-UCB-J PET-CT (Other)
Parkinson disease patients
Intervention: 18F-PE2I PET-CT (Other)
Parkinson disease patients
Intervention: MRI brain (Diagnostic Test)
Healthy controls
Intervention: 11C-UCB-J PET-CT (Other)
Healthy controls
Intervention: 18F-PE2I PET-CT (Other)
Healthy controls
Intervention: MRI brain (Diagnostic Test)
Outcomes
Primary Outcomes
Cross-sectional SV2A at Year 7
Time Frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional differences (%) in SV2A signal at Year 7 between Parkinson disease patients and controls.
Cross-sectional correlation between clinical scores and SV2A at Year 7
Time Frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Cross-sectional correlation between clinical scores and SV2A in Parkinson disease patients at Year 7.
Longitudinal SV2A change between baseline and Year 7
Time Frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Differences (%) in the rate of SV2A change between baseline and Year 7 between Parkinson disease patients and controls.
Longitudinal correlation between clinical scores and SV2A
Time Frame: Data analysis will be done when all subjects have undergone Year 7 evaluation.
Correlation between progression of the clinical scores and longitudinal SV2A changes in Parkinson disease patients.
Secondary Outcomes
- Cross-sectional DAT levels at Year 7(Data analysis will be done when all subjects have undergone Year 7 evaluation.)
- Cross-sectional correlation between clinical scores and DAT levels at Year 7(Data analysis will be done when all subjects have undergone Year 7 evaluation.)
- Longitudinal DAT level change between baseline and Year 7(Data analysis will be done when all subjects have undergone Year 7 evaluation.)
- Longitudinal correlation between clinical scores and DAT levels(Data analysis will be done when all subjects have undergone Year 7 evaluation.)
- Longitudinal correlation between SV2A and DAT levels(Data analysis will be done when all subjects have undergone Year 7 evaluation.)