View Clinical Trial (Medical Research Study)
Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism
| City: |
|
Minneapolis |
| State: |
|
Minnesota |
| Zip Code: |
|
55455 |
| Conditions: |
|
Parkinson Disease - Gaucher Disease - Idiopathic Rapid Eye Movement Sleep Disorder |
| Purpose: |
|
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 Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT01358474 |
| Primary Contact: |
|
Principal Investigator
Paul Tuite, MD
University of Minnesota - Clinical and Translational Science Institute
Christa Raszkowski
Phone: 612.624.7745
Email: cnru@umn.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Minneapolis, Minnesota 55455
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|