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NCT07809438PHASE2Recruiting

A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease

Michael J. Fox Foundation for Parkinson's Research

Start Date

9/18/2025

Completion Date

12/1/2027

Summary

This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study \[PPMI 015\] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the \[18F\]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol. This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data. All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Prodromal participant enrolled in the PPMI 015 sub study. 2. Able to provide consent. Exclusion Criteria: a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.

Interventions

DRUG

[18F] AV-133 PET Imaging

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Conditions

Prodromal Parkinson's Disease

Locations

Institute for Neurodegenerative Disorders

New Haven, Connecticut 06510

United States