Directly examine whether early (6-month) imaging with DaTscan and \[¹⁸F\] AV-133 will provide an early signal of disease progression in recently diagnosed untreated PD patients.
The study is a longitudinal, multi-center study to assess progression of DaTscan and \[18F\] AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24 months. Approximately 50 early PD participants and 100 Prodromal participants will be recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and follow up according to the Schedule of Activities for the respective cohort. Participants will undergo imaging assessments with DaTscan and \[18F\] AV-133 and clinical (motor, neuropsychiatric and cognitive) assessments. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.
Study Type
OBSERVATIONAL
Enrollment
50
Institute For Neurodegenerative Disorders
New Haven, Connecticut, United States
Boston University Medical Center
Boston, Massachusetts, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mean Rate of Change
The mean rates of change and the variability around the mean of imaging outcomes in early and Prodromal PD patients, and where appropriate the comparison of these rates between PD patient subsets at study intervals ranging from 6 months to 24 months. Specific examples of outcomes include dopamine transporter striatal uptake and vesicular monoamine transporter type-2 uptake. PD patient subsets may be defined by baseline assessments, genetic mutation, progression milestones and/or rate of clinical, imaging, or biomic change.
Time frame: 24 months
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