Protocol Number: 09-N-0010
Study Population: The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk-i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction-i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension. A total of 200 at-risk subjects undergo catecholaminergic biomarker testing by 6-[18F]fluorodopa brain and 6-[18F]fluorodopamine cardiac scanning. At-risk subjects with positive biomarkers are compared to at-risk subjects without positive biomarkers, in terms of development of PD during follow-up. Up to 20 control subjects are included, to add to a database of normal values for catecholaminergic biomarkers. Design: The study includes four phases-recruitment, screening, laboratory biomarkers testing, and follow-up. Recruitment is by advertisement and a web site questionnaire of self-reported risk. A screening examination is done at the NIH Clinical Center, to confirm risk status. Based on the screening examination results, subjects undergo clinical laboratory testing, to identify central and peripheral catecholaminergic denervation. In the follow-up phase, subjects are re-tested approximately every 18 months for a total of up to 5 re-evaluations (90 months, or 7.5 years), to detect onset of the characteristic movement disorder in PD and follow the status of catecholaminergic innervation. Outcome Measures: Primary: Diagnosis of PD by a board certified neurologist who is blinded to risk factor status and the results of catecholaminergic biomarkers testing. If PD diagnosed, time to diagnosis. Secondary: UPDRS; 6-[18F]fluorodopa brain scanning, 6-[18F]fluorodopamine cardiac scanning; CSF and plasma neurochemicals; neuropsychological rating scales; autonomic function testing; restrospective CSF proteomics; restrospective DNA analyses
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