Biomarkers of Risk of Parkinson Disease
|First Received Date ICMJE||October 17, 2008|
|Last Updated Date||February 10, 2017|
|Start Date ICMJE||October 15, 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 statistical 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 (18)F-DOPA brain and (18)F-dopamine 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 inpatient clinical laboratory testing, to identify central and peripheral catecholaminergic denervation. In the follow-up phase, subjects are re-tested as inpatients approximately every 18 months for a total of up to 5 re-evaluations (90 months, or 7.5 years), to detect the 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; (18)F-DOPA brain scanning, (18)F-dopamine 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 Groups/Cohorts||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||Active, not recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Individuals who report at least 3 of the following 4 risk factors at the protocol-specific website may be invited to the Screening Examination. All subjects must have ability to provide their own consent for participation in the study. Otherwise eligible candidate participants who are taking medications that would interfere with the scientific results may be included, if (1) the medications are held temporarily or safely substituted for, and (2) the medications are held while the participants are inpatients. The prescribing physician will be contacted, with the participant's permission, if withholding or substituting medication is considered.
|Ages||18 Years to 70 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|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|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||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||November 29, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP