Objective:

Characterization of the PET radiotracer, [¹⁸F]C05-05, in the PPMI Study

Background: Validation of imaging biomarkers in Parkinson disease (PD) is a major objective of the Parkinson Progression Marker Initiative (PPMI), a multicenter, international observational study of de novo PD. An imaging biomarker of brain synuclein deposition would aid in identifying and understanding PD pathophysiology and assist in developing of meaningful novel therapies. In this PPMI sub-study a novel PET radiotracer, [¹⁸F]C05-05, is being tested in participants in the PPMI study (reported in BioRxiv preprint). This approach allows for the efficient screening and initial validation of novel PET tracers in subjects well-characterized in the PPMI main study, which supports rapid study recruitment and correlation with existing PPMI data.

Method: Healthy Control (HC) and PD subjects were recruited from the PPMI Study and underwent an [¹⁸F]C05-05 PET scan at a single center. All PD participants were diagnosed with PD for greater than 4 years and responsive to dopaminergic therapy. All PD subjects had DaTscan SPECT imaging indicating significant striatal dopamine transporter (DaT) deficits (all HC had normal striatal DaT). Subjects received a target dose of 6 mCi [¹⁸F]C05-05 and underwent imaging from 90-120 minutes post-injection. Due to participation in the PPMI study, all PET imaging outcomes for participants will be correlated with robust demographic, clinical and biomarker outcomes. Safety data was also collected.

Results: Five PD (n=5, mean age 71.3, 4:1 male:female) and HC (n=5, mean age 66.7, 4:1 male:female) PPMI participants were recruited. All gave separate written informed consent for participation. For the PD cohort, all are treated for PD (mean Levodopa Equivalent Dose is 901.9) and the mean duration of diagnosis was 9.3 years. The mean MDS-UPDRS Part 3-Off score for the PD cohort was 42.6 vs. 3.2 for HC).  [¹⁸F]C05-05 administration was well-tolerated and no radiotracer-related adverse events were reported. [¹⁸F]C05-05 imaging for all subjects will be presented.

Conclusion: 1) [¹⁸F]C05-05 administration in this small study was safe and well-tolerated;

2) The PPMI Study provides a mechanism for rapid, initial characterization of novel imaging biomarkers in a well-characterized PD population with comparison to HC;

3) Imaging outcomes are not yet available as of the preparation of this abstract but will be presented in full.

References: 1) The Parkinson’s Progression Marker Initiative (PPMI). https://www.ppmi-info.org
2) Eberling JL, Dave KD, and Frasier MA. “α-synuclein imaging: a critical need for Parkinson’s disease research” J Parkinsons Dis. (2013) 3(4):565-7.
3) Endo H, et al. “Imaging α-synuclein pathologies in animal models and patients with Parkinson’s and related diseases.” BioRxiv https://doi.org/10.1101/2020.10.23.349860

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MDS Abstracts - https://www.mdsabstracts.org/abstract/characterization-of-a-novel-alpha-synuclein-pet-radiotracer-18fc05-05-in-a-ppmi-sub-study/