Biomarkers of Risk of Parkinson Disease
|ClinicalTrials.gov Identifier: NCT00775853|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2008
Last Update Posted : March 2, 2018
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:
- Family history of PD
- Loss of sense of smell
- Fall in blood pressure when standing up
- REM behavior disorder (a type of sleep disturbance)
Participants undergo the following tests and procedures:
- Screening examination
- Medical and neurological history and physical examination
- Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and thinking.
- Measurement of blood pressure and pulse rate while lying down and then standing up
- Blood draw for genetic testing
- Inpatient testing at the NIH Clinical Center for 2-3 days, including:
- Measurements while blowing against a resistance
- Measurements of blood pressure and pulse rate
- Blood draws for levels of various chemicals
- PET and MRI scanning
- Lumbar puncture (spinal tap)
- Skin electrical conduction test (test of sweat production)
- Skin and core temperature measurements
- Transcranial ultrasound (sound-wave test of the head)
- Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests listed above, excluding the genetic testing and spinal tap
|Condition or disease|
|Parkinson Disease Autonomic Nervous System Diseases Pure Autonomic Failure|
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 :||Observational|
|Actual Enrollment :||88 participants|
|Official Title:||Biomarkers of Risk of Parkinson Disease|
|Study Start Date :||October 16, 2008|
- Diagnosis of Parkinson disease (PD) based on the characteristic movement disorder in PD, confirmed by Unified Parkinson Disease Rating Scale (UPDRS).
- Brain 6-[18F]fluorodopa-derived radioactivity; cardiac 6-[18F]fluorodopamine-derived radioactivity; CSF neurochemicals; olfactory testing; autonomic function tests; neurobehavioral rating scales.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775853
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||David S Goldstein, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|