NCT07265596

Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)

Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Michael J. Fox Foundation for Parkinson's Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The Parkinson's Progression Marker Initiative (PPMI) is an observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etiology and course and to provide the necessary tools to enhance the likelihood of success of therapeutics studies to slow PD progression (ClinicalTrials.gov Identifier: NCT01141023). A key focus of PPMI is to identify biomarkers during the period when PD neurodegeneration is already present, but symptoms of PD have not yet occurred. This prodromal cohort would enable us to investigate PD biomarker signatures prior to onset of typical symptoms of PD. The study is a longitudinal, multi-center study to assess progression of \[18F\]AV-133 imaging in Prodromal PD participants. The PPMI 015 study will enroll participants from the PPMI Clinical (002) study. Participants will be followed annually 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 \[18F\]AV-133 PET imaging targeting the vesicular monoamine transporter. All participants will undergo an initial \[18F\]AV-133 PET imaging scan at baseline with repeat imaging at 12 months and 24 months.

Conditions

• Prodromal Parkinsons Disease

Interventions

Type	Name	Description
DRUG	[18F] AV-133 PET Imaging	Prodromal 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.

Timeline

• Start date: 2023-10-30
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

8 sites across 6 countries: United States, Canada, Germany, Israel, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study