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| Name | Class |
|---|---|
| Institute for Neurodegenerative Disorders | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTROPANE® | Experimental | ALTROPANE® dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTROPANE® | Drug | ALTROPANE® SPECT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimize ALTROPANE® dosing and the image acquisition protocol to develop a quantitative imaging outcome that would enhance ALTROPANE® reliability, ease of use and ease of analysis. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate a state-of-art automated objective striatal analysis tool for ALTROPANE® and to test the reliability of these quantitative outcomes. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Molecular NeuroImaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molecular NeuroImaging | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C102282 | N-iodoallyl-2-carbomethoxy-3-(4-fluorophenyl)tropane |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |