Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

NCT01358474 | Completed

• 1 other identifier: 10-DAT-003
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Gaucher Disease; Idiopathic Rapid Eye Movement Sleep Disorder

Keywords

Parkinson disease; idiopathic rapid eye movement sleep disorder; Gaucher disease; healthy volunteer

Outcome Measures

Primary Outcomes (1)

• single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss

  Visit 1

Study Arms (3)

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 Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Minnesota, Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gaucher Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Study Officials

• Paul Tuite, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 23, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)