Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies
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.
• Healthy Controls inclusion criteria:
‣ Enrolled in the PPMI 002 Clinical study as a healthy control participant
⁃ Any gender aged 50 to 75 years of age
⁃ Negative CSF α-synuclein seed amplification assay (SAA)
⁃ Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.
⁃ 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.
⁃ Cognitively intact with Montreal Cognitive Assessment (MoCA) greater than or equal to 26 at the last PPMI annual visit which was within the past 18 months.
• Parkinson's Disease and Prodromal PD inclusion criteria:
‣ Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant
⁃ Any gender aged 50 to 80 years of age
⁃ Positive CSF SAA
⁃ A current or previously acquired brain MRI (since the onset of motor symptoms for PD or since enrolled in PPMI for the prodromal PD) without evidence of significant neurological pathology other than changes expected for PD.
⁃ Montreal Cognitive Assessment (MoCA) greater than or equal to 24 at the last PPMI annual visit which was within the past 18 months.
• Multiple System Atrophy (MSA) inclusion criteria:
‣ Any gender aged 50 to 75 years of age
⁃ Clinically established MSA or Clinically Probable MSA according to the Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy (Wenning et al., 2022)
⁃ Positive CSF SAA
⁃ A current or previously acquired brain MRI (since the onset of motor symptoms attributed to MSA) without evidence of significant neurological pathology other than the pathology expected for MSA.
⁃ Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA.