Biomarkers of Risk of Parkinson Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00775853|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2008
Last Update Posted : June 30, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||89 participants|
|Official Title:||Biomarkers of Risk of Parkinson Disease|
|Actual Study Start Date :||May 27, 2009|
PD Risk Individuals
Individuals who may be at risk for developing PD, because of genetic risk; olfactory dysfunction; symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or orthostatic hypotension.
- Parkinson Disease Diagnosed [ Time Frame: annually within 7.5 years ]The primary objective of this study is to determine whether among people at increased statistical risk for developing PD those with clinical laboratory biomarkers of central or cardiac catecholamine deficiency are diagnosed with PD during follow-up, whereas those without evidence of central or peripheral catecholamine deficiency are not diagnosed with PD during follow-up.
- Results of clinical laboratory tests such as 18F-DOPA brain and 18F dopamine cardiac scans [ Time Frame: annually within 7.5 years ]A secondary objective is to determine whether among people at increased statistical risk for developing PD, conversion from negative to positive biomarkers of central or peripheral catecholamine deficiency precedes being diagnosed with motor symptoms and signs of PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|