Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01358474
First received: May 20, 2011
Last updated: November 5, 2013
Last verified: November 2013
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 5, 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
Parasomnias
Parkinson Disease
Parkinsonian Disorders
Sleep Disorders
Basal Ganglia Diseases
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Lipidoses
Lysosomal Storage Diseases
Lysosomal Storage Diseases, Nervous System
Mental Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Sphingolipidoses
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014