A Phase 2 interventional study of [18F] AV-133 PET Imaging in Prodromal Parkinson's Disease, sponsored by Michael J. Fox Foundation for Parkinson's Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Michael J. Fox Foundation for Parkinson's Research · Phase 2, Interventional, and Diagnostic
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Michael J. Fox Foundation for Parkinson's Research is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
Drug: [18F] AV-133 PET Imaging
The study will compare the performance of \[18F\]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.
Comparison of tracer uptake between two camera using Standardized Uptake Value ratio
To compare \[18F\]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants
Time frame: Up to 24 months
Longitudinal comparison of quantitative signals (SUVR) between two PET cameras
To compare the longitudinal regional change in \[18F\]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET
Time frame: 24 months
Correlation of AV133 longitudinal change to clinical motor change
Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in MDS-UPDRS score reported as correlation coefficient.
Time frame: 24 months
Correlation of AV133 longitudinal change to clinical cognitive change
Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in Montreal Cognitive Assessment (MoCA) score reported as correlation coefficient.
Time frame: 24 months
Correlation of AV133 Longitudinal change to CSF biomarker
Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in cerebrospinal fluid (CSF)- seed amplification assay (SAA) level reported as correlation coefficient.
Time frame: 24 months
Plan to share: Yes — All data obtained during the conduct of this study will be sent to the Laboratory of Neuro Imaging (LONI) in Los Angeles, California to be stored indefinitely for research purposes. Research data will be made available to researchers to conduct analyses related to PD and other disorders. Researchers will be required to comply with the PPMI data agreement to receive data. All personally identifiable information will be removed before it is shared outside the study
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Michael J. Fox Foundation for Parkinson's Research