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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gaucher Disease Genetic Diseases, Inborn Idiopathic Rapid Eye Movement Sleep Disorder Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Sphingolipidoses Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota, Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Visit 1

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

GE Healthcare

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2018
First posted: May 23, 2011
Registry last updated: Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed