The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).
A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
Able to provide informed consent.
Male or Female (females must meet additional criteria specified below as applicable)
Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133
Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.
Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Single group
[18F] AV-133 PET Imaging
DrugProdromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with \[18F\]AV-133 under this protocol at baseline, 12-month and 24 months.
[18F]AV-133 mean rate of change and variability
The mean rates of change and the variability around the mean of \[18F\]AV-133 PET SUVr in Prodromal PD patients, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months.
[18F]AV-133 prediction of clinical motor progression
Predictive value of \[18F\]AV-133 imaging Standardized Uptake Value ratio \[SUVr\] at baseline for longitudinal clinical progression, defined as change in Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), scale \[0-260\]
[18F]AV-133 prediction of clinical cognitive progression
Predictive value of \[18F\]AV-133 imaging Standardized Uptake Value ratio \[SUVr\] at baseline for longitudinal cognitive progression, defined as change in cognitive scales Montreal Cognitive Assessment (MoCA), scale \[0-30\]
[18F]AV133 cutoff for clinical PD
Determine \[18F\]AV-133 SUVr cutoff value for predicting development of clinical diagnosis of PD in people with Prodromal PD. Compare \[18F\]AV-133 SUVr with DaTscan SBR cutoffs for predicting the development of clinical diagnosis of PD in people with Prodromal PD.
[18F] AV133 correlation with DaTscan
Correlation between the longitudinal change of \[18F\]AV-133 and DaTscan.
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