Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Parkinsons Disease, Neurology, Metabolic |
| Therapuetic Areas: | Neurology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/14/2018 |
| Start Date: | July 2011 |
| End Date: | December 2018 |
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.
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.
Inclusion Criteria:
- Written consent prior to study by the subject or their surrogate
- Subjects >/= 18 years and
- 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
We found this trial at
1
site
Click here to add this to my saved trials
