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NCT03648905 · ClinicalTrials.gov registry record
Clinical Laboratory Evaluation of Chronic Autonomic Failure
A clinical trial of Parkinson's Disease and Multiple System Atrophy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Active
- Registry status
- 89
- Enrollment target
- 1
- Study location
NCT03648905: Active study of Parkinson's Disease and Multiple System Atrophy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT03648905 is a study of Parkinson's Disease and Multiple System Atrophy that is active but no longer recruiting, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 89 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648905, a study of Parkinson's Disease and Multiple System Atrophy, is active but no longer recruiting, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- ACTIVE NOT RECRUITING
- Registry status
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure. Objective: To improve testing for conditions that cause autonomic nervous system failure. Eligibility: People ages 18 and older in one of these categories: * Their blood pressure drops when they get up. * They have had a heart transplant or bilateral endoscopic thoracic sympathectomies or have had or will have renal sympathetic ablation Design: All participants will be screened with: * Medical history * Physical exam * Blood and urine tests Some participants will be screened with: * Heart and breathing tests * IV placement into an arm vein * Tilt table testing: Participants lie on a table that tilts while an IV is used to draw their blood. Participants may stay in the hospital for up to 1 week depending on their tests. Tests may include repeats of screening tests and: * Sweat testing: A drug is placed on the skin to cause sweating. Sensors on the skin measure moisture. * Lumbar puncture: A needle is inserted between the bones in the back to collect fluid. * MRI and PET/CT scan: Participants lie on a table that slides into a scanner. For the PET/CT, a small amount of a radioactive chemical will be injected with a small amount of a radioactive chemical. * Bladder catheter placement to collect urine * Skin biopsies: A punch tool removes a small skin sample. * Tests to see how the pupils react to light * Smelling tests * Thinking and memory tests * Questionnaires Participants may have a visit about 2 years later to repeat tests.
Primary Outcome
Neurobehavioral rating scales include the University of Pennsylvania Smell Identification Test (UPSIT), Montreal Cognitive Assessment (MoCA), and Uniform Parkinson s Disease Rating Scale (UPDRS). Neurochemical data are from assays of catechols and related compounds in plasma or cerebrospinal fluid. Neuroimaging data are from 18F-DOPA, 18Fdopamine, 13Nammonia, and 11Cmethylreboxetine positron emission tomographic (PET) scanning and MRI. Immunofluorescence microscopy is used to quantify immunoreac
Conditions Studied
Interventions
- DRUG 13N-Ammonia
- DRUG 18F-DOPA
- DRUG 11C-Methylreboxetine (11C-MRB)
- DRUG 18F-Dopamine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2029-12-31 |
What the registry record for NCT03648905 still lists
NCT03648905 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 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 4 interventions - of which 13N-Ammonia is the first listed.
NCT03648905 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03648905 about?
NCT03648905 is a clinical study titled "Clinical Laboratory Evaluation of Chronic Autonomic Failure". Background: The autonomic nervous system controls automatic body functions. Researchers want to improve the tests used to diagnose autonomic failure. Orthostatic hypertension is a drop in blood pressure when a person stands up. Researchers want to focus on this sign of autonomic failure. Objective...
What is the current status of trial NCT03648905?
This trial is currently active not recruiting. The enrollment target is 89 participants. The study started on 2018-09-06. Estimated completion is 2029-12-31.
What conditions does trial NCT03648905 study?
This clinical trial studies the following conditions: Parkinson's Disease, Multiple System Atrophy, Autonomic Failure.
What interventions are being tested in trial NCT03648905?
The interventions under investigation include: 13N-Ammonia (DRUG), 18F-DOPA (DRUG), 11C-Methylreboxetine (11C-MRB) (DRUG), 18F-Dopamine (DRUG).
Who is sponsoring clinical trial NCT03648905?
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 NCT03648905 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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89 61st of 158 higher than 98 of 158 other Parkinson's Disease trials
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