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.
Ability to comply with the study procedures and attend follow-up visits.
Written informed consent from the participant or legal guardian.
Male or Female between 45 years and 85 years of age (Females must meet additional criteria specified below, as applicable) a. 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]PI-2620 or DaTscan.
Diagnosis of progressive supranuclear palsy (PSP) based on the Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria (Höglinger et al., 2017).
Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine, within 6 months of Screening Visit for non-PPMI participants or within 6 months of Baseline Visit for PPMI participants.
Any structural abnormality or finding on previously obtained or screening brain MRI suggestive of clinically significant neurological disorders other than the diseases of interest (in the opinion of the investigator).
Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection, would render the participant unsuitable for the study enrollment.
Parallel
[18F]PI-2620
DrugAll participants will undergo PET imaging using the \[18F\]PI-2620 tau-binding tracer.
Comparison of tau binding between study cohort using Standardized Uptake Value ratio ( SUVr)
Determination of \[18F\]PI-2620 binding in brain regions in all participants with NX acquired images to compare tau binding between study cohorts.
Comparison of Tau imaging to clinical profile
To compare \[18F\]PI-2620 binding with clinical assessments including motor and cognitive rating scale.
Comparison of Tau imaging to biomarker profile
To compare \[18F\]PI-2620 binding with CSF Synuclein Seed Amplification status. To compare \[18F\]PI-2620 binding with plasma phosphoTau217.
Compare Tau binding between Standard and high-resolution PET camera in all participants using SUVr.
To compare the tau binding in all participants between the NX and conventional PET scanner (Siemens Biograph mCT).
Compare longitudinal change
To compare longitudinal change in \[18F\]PI-2620 binding over a period of 12 months across all cohorts.
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Michael J. Fox Foundation for Parkinson's Research
Lead sponsor
Institute for Neurodegenerative Disorders
Collaborator
