Biomarkers of Risk of Parkinson Disease
|First Received Date ICMJE||October 17, 2008|
|Last Updated Date||July 12, 2014|
|Start Date ICMJE||October 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Diagnosis of Parkinson disease (PD) based on the characteristic movement disorder in PD, confirmed by Unified Parkinson Disease Rating Scale (UPDRS).|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00775853 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Brain 6-[18F]fluorodopa-derived radioactivity; cardiac 6-[18F]fluorodopamine-derived radioactivity; CSF neurochemicals; olfactory testing; autonomic function tests; neurobehavioral rating scales.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Biomarkers of Risk of Parkinson Disease|
|Official Title ICMJE||Biomarkers of Risk of Parkinson Disease|
This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that show that the disease process is actually going on, and if people who have abnormal biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson disease (PD) might identify people who are healthy now but may develop the disease later in life.
Healthy volunteers and people who have certain risk factors for developing PD who are between 18 and 70 years of age may be eligible for this study. People with the following risk factors are included:
Participants undergo the following tests and procedures:
Objective: This Protocol is to test whether individuals with putative risk factors for Parkinson disease (PD) have abnormal values for biomarkers of central or peripheral catecholaminergic innervation and whether at-risk individuals with positive biomarkers develop PD within up to 7.5 years of follow-up.
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.
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; retrospective CSF proteomics; retrospective DNA analyses.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||220|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Individuals with one or more of the following characteristics will be considered to be at risk and eligible for entering the Screening Examination phase. Priority will go to those with multiple risk factors. Subjects with at least 3 of the 4 risk factors will be invited to the Screening Examination. Control subjects will have none of these characteristics:
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00775853|
|Other Study ID Numbers ICMJE||090010, 09-N-0010|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP