An observational study in Parkinson Disease, Gaucher Disease and Idiopathic Rapid Eye Movement Sleep Disorder, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by University of Minnesota · Observational
The purpose of this study is to determine if participants have changes in dopamine cells in their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement disorders such as essential tremor or dystonia. DaTSCAN, which is also known as 123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive iodine, it allows doctors to use a special machine called single photon emission computed tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain and help determine if there are changes in brain dopamine. It is hoped that this study will help doctors detect the presence of dopamine changes even before symptoms are present. This study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g., those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 56 is below the median of 96 across 1,056 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Investigators' clinical practice (e.g., neurology clinic, sleep disorder clinic, etc).
Exclusion Criteria:
Subjects diagnosed with Parkinson's disease (PD)
Subjects at-risk for developing PD (e.g., those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous or homozygous for Gaucher's disease (GBA) mutations)
Healthy volunteers
single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss
Time frame: Visit 1
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Minnesota