The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinson's Disease from other movement disorders.
The early detection and monitoring of neurodegenerative diseases including Parkinson's disease (PD), Alzheimer's disease (AD), Dementia with Lewy Bodies (DLB), and other dementias and movement disorders represent a very significant unmet medical need. Disease mechanisms are gradually becoming understood, and disease-modifying drugs are emerging that target the specific molecular pathology underlying each of these diseases. Tools for accurate and early differential diagnosis are thus necessary to determine the appropriate treatment for patients and to minimize inappropriate use of potentially harmful treatments. In addition, such diagnostic imaging tools are expected to permit monitoring of disease progression and will thus accelerate testing and development of disease-modifying drugs. Furthermore, the new imaging test may be useful as a prognostic tool by identifying humans suffering from neurodegenerative diseases before the clinical manifestations become evident.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
170
222 MBq (6 mCi)
Research Site
Scottsdale, Arizona, United States
Research Site
Sun City, Arizona, United States
Research Site
New Haven, Connecticut, United States
Sensitivity of visual read of AV-133 PET scan vs. standard of truth
Sensitivity will be calculated as the percent of true positives which are correctly identified An expert, consensus diagnosis of PD performed by a panel of movement disorders specialists will be used as the standard of truth.
Time frame: 18 months
Specificity of visual read of AV-133 PET scan vs. standard of truth
Specificity will be calculated as the percent of true negatives which are correctly identified. An expert, consensus diagnosis of PD performed by a panel of movement disorders specialists will be used as the standard of truth.
Time frame: 18 months
Inter-rater reliability of the visual read
Fleiss' kappa
Time frame: 18 months
Intra-rater reliability of the visual read
Intra-class kappa
Time frame: 18 months
Probability of progressive motor skill impairment
Compare rates of progressive impairment using PD rating scale in subjects with positive AV-133 PET scan vs. progressive impairment in subjects with negative AV-133 PET scan
Time frame: 18 months
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Research Site
Kansas City, Kansas, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Cleveland, Ohio, United States
...and 5 more locations