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Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358474
First Posted: May 23, 2011
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss [ Time Frame: Visit 1 ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Investigators' clinical practice (e.g., neurology clinic, sleep disorder clinic, etc).
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358474


Locations
United States, Minnesota
University of Minnesota, Center for Magnetic Resonance Research
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
GE Healthcare
Investigators
Principal Investigator: Paul Tuite, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01358474     History of Changes
Other Study ID Numbers: 10-DAT-003
First Submitted: May 20, 2011
First Posted: May 23, 2011
Last Update Posted: January 27, 2017
Last Verified: January 2017

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:
Parkinson Disease
Sleep Wake Disorders
Parasomnias
Gaucher Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics