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NCT01496599 · ClinicalTrials.gov registry record
Imaging Biomarkers in Parkinson s Disease
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 62
- Enrollment target
NCT01496599: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01496599 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496599 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 62 participants
- Enrollment target
Study Summary
Background: \- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This study will use different ways of imaging the brain and brain chemicals to look at PD. It will compare brain imaging in people who definitely have PD to people who might have PD and to people without signs of PD. It will provide more information how the brain in people with PD changes over time. Objectives: \- To understand the changes that occur in the brains of people with Parkinson s disease. Eligibility: * Individuals at least 18 years of age who have definite or possible Parkinson s disease. * Healthy volunteers at least 18 years of age. Design: * Participants will have a screening visit with a physical exam and medical history. * Participants will visit the National Institutes of Health Clinical Center every 18 month or 3 years for up to 9 years. There will be up to 6 total visits. Most visits will last 5 to 6 hours a day for 1 to 3 days. Some or all of the following tests will be performed at each visit: * Magnetic resonance imaging to take pictures of the brain. Some of these tests will be done at rest. Others will require participants to perform an activity during the scan. * Medication withdrawal for 12 hours overnight for people taking PD medications. This may be done before some scans. Participants who feel unwell when they stop taking medications will be allowed to start taking them again. * Participants will continue with the follow up visits until the end of the study.
Primary Outcome
-Structural MRI (SWI images): The primary outcome measure is the difference in susceptibility changes in iron-rich structures (ie. The SN, red nucleus, striatum) across groups and within groups over time.-Clinical presentation: We will evaluate how the prodromal symptoms influence the progression to clinical PD.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2012-01-24 |
What the finished NCT01496599 record still lists
NCT01496599 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01496599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01496599 about?
NCT01496599 is a clinical study titled "Imaging Biomarkers in Parkinson s Disease". Background: \- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This s...
What is the current status of trial NCT01496599?
This trial is currently completed. The enrollment target is 62 participants. The study started on 2012-01-24.
Who is sponsoring clinical trial NCT01496599?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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