The Dutch Parkinson-GBA Cohort Study (DUPARG) Cognitive and cholinergic function analysis in Dutch Parkinson*s patients with GBA variations.
Recruiting
- Conditions
- ParkinsonParkinson's disease10028037
- Registration Number
- NL-OMON50798
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 205
Inclusion Criteria
- Diagnosis Parkinson*s disease according to UK Parkinson's Disease Society
Brain Bank criteria
- Willingness to cooperate and sign written informed consent
Exclusion Criteria
- The refusal to be informed about an unforeseen clinical finding, Exclusion
from PET: - pregnant or breast feeding women, Exclusion from MRI scan: - MRI
incompatible implants in the body (e.g. prothesis, pacemakers, implanted heart
valves.) - Any risk of having metal particles in the eyes due to manual work
without proper eye protections - Tattoos containing red pigments that form a
safety risk
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the regional VAChT binding, as a measure of brain<br /><br>cholinergic innervation, measured with FEOBV PET imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include (1) Neuropsychological assessment (NPA) covering<br />all cognitive domains including questionnaires, (2) GCase activity measured<br />using a flow cytometry based assay of peripheral blood mononuclear cells<br />(PBMCs), (3) [18F]DOPA PET to evaluate the dopaminergic system, (4) Magnetic<br />Resonance Imaging (MRI) and, (5) relevant clinical characteristics of the<br />patients.</p>