Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism
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Purpose
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.
| Condition |
|---|
|
Parkinson Disease Gaucher Disease Idiopathic Rapid Eye Movement Sleep Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism |
- single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
PD Subjects
Subjects diagnosed with Parkinson's disease (PD)
|
|
At-risk for 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 Controls
Healthy volunteers
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Investigators' clinical practice (e.g., neurology clinic, sleep disorder clinic, etc).
Inclusion Criteria:
- Written consent prior to study by the subject or their surrogate
- Subjects >/= 18 years and</=85 years
- Diagnosis of Parkinson's disease, family history of Parkinson's disease, idiopathic rapid eye movement sleep behavioral disorder, age-matched controls, Gaucher's disease or carrier of Gaucher's gene mutation
- Females using adequate methods of birth control or not of childbearing potential
Exclusion Criteria:
- Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- Any exposure to investigational drugs within 4 weeks prior to Visit 1
- Any exposure to radiopharmaceuticals within 4 weeks prior to Visit 1
- Pregnancy
- Breastfeeding
- Severe swallowing problems
- Known sensitivity or allergy to iodine containing products
- Advanced liver or renal disease
Contacts and Locations| Contact: Christa Raszkowski | 612.624.7745 | cnru@umn.edu |
| United States, Minnesota | |
| University of Minnesota, Center for Magnetic Resonance Research | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: Paul Tuite, MD | |
| Principal Investigator: | Paul Tuite, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01358474 History of Changes |
| Other Study ID Numbers: | 10-DAT-003 |
| Study First Received: | May 20, 2011 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Parkinson disease idiopathic rapid eye movement sleep disorder Gaucher disease healthy volunteer |
Additional relevant MeSH terms:
|
Gaucher Disease Parkinson Disease Sleep Disorders Parasomnias Parkinsonian Disorders Sphingolipidoses Lysosomal Storage Diseases, Nervous System Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolism, Inborn Errors Genetic Diseases, Inborn Lipidoses |
Lipid Metabolism, Inborn Errors Lysosomal Storage Diseases Metabolic Diseases Lipid Metabolism Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Dopamine Dopamine Agents Dopamine Agonists Cardiotonic Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013