ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 12/17/2016 |
| Start Date: | November 2006 |
| End Date: | December 2011 |
Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease
After a screening evaluation including baseline clinical laboratory testing, a physical and
neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE®
followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second
injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6
weeks of the injection 1.
neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE®
followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second
injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6
weeks of the injection 1.
The underlying goal of this open label imaging study is to optimize the imaging outcome for
ALTROPANE® in mild to moderate PD subjects. All study procedures will be conducted at the
Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New
Haven, CT. Subjects with PD (n=15) will be recruited to undergo ALTROPANE® SPECT. All
subjects will undergo written informed consent and a screening evaluation including baseline
clinical laboratory testing, a physical and neurological evaluation. Subjects will be asked
to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic
imaging. Subjects will be asked to undergo a second imaging visit two-six weeks following
the initial imaging visit to assess the reproducibility of the imaging outcome. The imaging
analyses will be performed by an image-processing specialist who will remain masked to
clinical severity. The primary imaging outcome measure will be the brain regional
distribution volumes expressed as a target region to occipital ratio. Striatal regions of
interests for caudate and putamen will be defined and placement standardized based on
previously optimized region placement protocols. Imaging data will also be analyzed using an
automated objective striatal analysis software package.
ALTROPANE® in mild to moderate PD subjects. All study procedures will be conducted at the
Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New
Haven, CT. Subjects with PD (n=15) will be recruited to undergo ALTROPANE® SPECT. All
subjects will undergo written informed consent and a screening evaluation including baseline
clinical laboratory testing, a physical and neurological evaluation. Subjects will be asked
to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic
imaging. Subjects will be asked to undergo a second imaging visit two-six weeks following
the initial imaging visit to assess the reproducibility of the imaging outcome. The imaging
analyses will be performed by an image-processing specialist who will remain masked to
clinical severity. The primary imaging outcome measure will be the brain regional
distribution volumes expressed as a target region to occipital ratio. Striatal regions of
interests for caudate and putamen will be defined and placement standardized based on
previously optimized region placement protocols. Imaging data will also be analyzed using an
automated objective striatal analysis software package.
Inclusion Criteria:
- The participant is 30 years or older at time of PD diagnosis.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of idiopathic Parkinson's disease of < 7
years.
- Hoehn and Yahr stages I-III.
- Negative drug screen
Exclusion Criteria:
- The participant has atypical or drug-induced Parkinson's disease.
- The participant has dementia.
- The participant has a clinically significant clinical laboratory value and/or
clinically significant unstable medical or psychiatric illness.
- Treatment within the six months prior to screening with bupropion, methylphenidate,
reserpine, alpha methyldopa, or amphetamine.
- The participant has a history of alcohol, narcotic, or any other drug abuse within
the past 2 years.
- The participant has received an investigational drug within 60 days of screening
visit.
- Pregnancy
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