MODAG GmbH
This is a single-center, open-label clinical study designed to evaluate the imaging characteristics and safety of \[¹⁸F\]MODAG-009 in participants with Parkinson's disease (PD), Multiple system atrophy (MSA), and Healthy controls (HC). Approximately 13 participants will be enrolled in this study. Each participant will receive a single intravenous injection of \[¹⁸F\]MODAG-009, followed by PET imaging using the investigational United Imaging NeuroEXPLORER (NX) camera.
This is a single-center, open-label clinical study designed to evaluate the imaging characteristics and safety of \[¹⁸F\]MODAG-009 in participants with PD, MSA, and HC. All eligible participants receive a single IV injection of \[¹⁸F\]MODAG-009 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner for up to 3 hours post-injection, according to an Image Acquisition Plan (IAP). Structural MRI (obtained under PPMI-002 or as part of routine care/screening) is used for anatomical localization and region-of-interest definition. Safety assessments include phys…
Inclusion Criteria: * Healthy Controls inclusion criteria: 1. Enrolled in the PPMI 002 Clinical study as a healthy control participant 2. Any gender aged 50 to 75 years of age 3. Negative CSF α-synuclein seed amplification assay (SAA) 4. Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology. 5. Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) score of \<6 at the last PPMI annual visit which is within the past 18 months. 6. Cognitively intact with Montreal Cognitive Assessment (Mo…
Participants enrolled in the study will receive a single IV injection of \[¹⁸F\]MODAG-009 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner.
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