About this trial
The study is a longitudinal, single-center study to assess progression of \[18F\]AV-133 imaging in PD participants. Participants will be followed for up to 12 months. Approximately 45 PD participants and 5 healthy control participants will be recruited from the ongoing PPMI Clinical 002 study. Participants will be comprehensively assessed at Baseline and follow up according to the Schedule of Activities. Participants will undergo PET imaging assessments with \[18F\]AV-133. After tracer injection, participants will be imaged on PET cameras at each imaging timepoint-one with the NX camera and one with a standard PET camera-in accordance with the Image Acquisition Protocol (IAP).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants over the age of 18 who are enrolled in the PPMI Clinical protocol with a diagnosis of Parkinson's disease (PD) or Healthy Control participants enrolled in the PPMI Clinical protocol.
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
[18F]AV-133
DrugThis protocol is a sub-study under the PPMI Program. It is a longitudinal, single-center study to assess the performance of \[18F\]AV-133 imaging using high and standard resolution PET in individuals enrolled with Parkinson's disease (PD) for up to 12 months.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR)
To compare longitudinal change in \[18F\]AV-133 PET SUVR in the striatum and other brain regions acquired with NeuroEXPLORER (NX) camera to that acquired with Siemens Biograph camera.
Sponsors and contacts
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