This 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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael J. Fox Foundation for Parkinson's Research

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • [18F]AV-133

    Drug

    This 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

50 Participants
are divided into 1 treatment group
Group A: Parkinson's Disease & Healthy ControlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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