Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

NCT ID: NCT01358474

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

PD Subjects

Subjects diagnosed with Parkinson's disease (PD)

No interventions assigned to this group

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)

No interventions assigned to this group

Healthy Controls

Healthy volunteers

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Tuite, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota, Center for Magnetic Resonance Research

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

10-DAT-003

Identifier Type: -

Identifier Source: org_study_id