Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT01358474

Collaborator

GE Healthcare (Industry)

Enrollment

Location

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Gaucher Disease Idiopathic Rapid Eye Movement Sleep Disorder

Study Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

Actual Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

single photon computed tomography (SPECT) imaging following administration of a visual adjunct imaging agent that detects dopamine loss [Visit 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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