Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Gaucher Disease; Idiopathic Rapid Eye Movement Sleep Disorder

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, Center for Magnetic Resonance Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators' clinical practice (e.g., neurology clinic, sleep disorder clinic, etc).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy Controls; Healthy volunteers
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss	Visit 1

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Paul Tuite, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: healthy volunteer; Parkinson disease; Gaucher disease; idiopathic rapid eye movement sleep disorder
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Lipidoses; Lipid Metabolism, Inborn Errors; Parkinson Disease; Sleep Wake Disorders; Parasomnias; Parkinsonian Disorders; Gaucher Disease
• Other Study ID Numbers: 10-DAT-003