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Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease Using [18F]PI-2620: A High-resolution PET Imaging Study Using NeuroEXPLORER (NX PI-2160 in PD)
The study aims to evaluate the burden of tau pathology in people with Sporadic and LRRK2 PD via in vivo imaging using the tau tracer, \[18F\]PI-2620, and a high resolution PET camera, NeuroEXPLORER.
The purpose of this study to compare how well \[18F\] PI-2620, a PET radiotracer targeting Tau protein, bind to brain regions in people with Parkinson's disease (PD), Progressive Supranuclear Palsy, Corticobasal Syndrome, and healthy volunteers. The study is planned to be conducted over a period of two years. The study aims to assess the tau burden in PD compared to diseased and healthy controls with PET imaging using \[18F\]PI-2620 and utilizing the new NX PET camera. The study will include subjects already enrolled in the PPMI study to enable efficient enrollment. The study will utilize clinical and imaging assessments obtained during the PPMI study visit to reduce the subject burden and enable longitudinal PPMI study data used in the study analysis. In the first year, half of the cohort will be recruited including 10 sporadic PD, 10 LRKK2 PD, 5 PSP/CBS, and 5 Healthy controls. The first-year cohorts, may be scanned on both the NX and the conventional PET camera to allow for comparison of tau deposits visualization between the two camera systems. During the second year, remaining cohorts will be recruited to acquire the \[18F\]PI-2620 image using the NX PET camera. In order to investigate the temporal change in tau pathology in PD, participants recruited in the first year will be followed up at 12 months with repeat imaging with NX.
Age
45 - 85 years
Sex
ALL
Healthy Volunteers
Yes
Institute for Neurodegenerative Disorders / XingImaging, LLC
New Haven, Connecticut, United States
Start Date
May 12, 2025
Primary Completion Date
April 1, 2027
Completion Date
June 1, 2027
Last Updated
June 13, 2025
60
ESTIMATED participants
[18F]PI-2620
DRUG
Lead Sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborators
NCT02119611
NCT07310264
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976