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NCT00775853 · ClinicalTrials.gov registry record
Biomarkers of Risk of Parkinson Disease
A clinical trial of Parkinson Disease and Pure Autonomic Failure, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 89
- Enrollment target
- 1
- Study location
NCT00775853: Completed study of Parkinson Disease and Pure Autonomic Failure, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00775853 is a study of Parkinson Disease and Pure Autonomic Failure that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 89 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00775853, a study of Parkinson Disease and Pure Autonomic Failure, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
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) * Electrocardiogram * 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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 13N-Ammonia
- DRUG 6-[18F]Fluorodopamine
- DRUG 6-[18F]Fluorodopa
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2009-05-27 |
| Est. Completion | 2023-01-11 |
What the finished NCT00775853 record still lists
NCT00775853 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which 13N-Ammonia is the first listed.
NCT00775853 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00775853 about?
NCT00775853 is a clinical study titled "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 du...
What is the current status of trial NCT00775853?
This trial is currently completed. The enrollment target is 89 participants. The study started on 2009-05-27. Estimated completion is 2023-01-11.
What conditions does trial NCT00775853 study?
This clinical trial studies the following conditions: Parkinson Disease, Pure Autonomic Failure, Autonomic Nervous System Diseases.
What interventions are being tested in trial NCT00775853?
The interventions under investigation include: 13N-Ammonia (DRUG), 6-[18F]Fluorodopamine (DRUG), 6-[18F]Fluorodopa (DRUG).
Who is sponsoring clinical trial NCT00775853?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00775853 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00775853's enrollment target sits among peer trials
89 100th of 297 higher than 198 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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