RecruitingMultiple System Atrophy (MSA)Healthy AdultParkinson Disease
Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies
Eligible age
50–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: MODAG GmbH
You may qualify if…
- ✓ 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 (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:
You may not qualify if…
- ✕ All Cohorts:
- ✕ 1. Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
- ✕ 2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- ✕ 3. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit.
- ✕ 4. 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.
- ✕ 5. Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
- ✕ 6. Currently being treated with and unable to safely hold antiplatelets (other than low dose aspirin up to 100mg/day) or anticoagulants prior to the procedure that might preclude safe attempt of Lumbar puncture, if applicable.
- ✕ 7. Condition that precludes the safe performance of routine lumbar puncture, if applicable, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant and uncorrected coagulopathy or thrombocytopenia.
Where it's recruiting
Connecticut
New Haven
Source: ClinicalTrials.gov · NCT07640555 · last updated 2026-06-10