Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies (NCT07640555) | Clinical Trial Compass
RecruitingEarly Phase 1
Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies
United States13 participantsStarted 2026-05-13
Plain-language summary
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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Enrolled in the PPMI 002 Clinical study as a healthy control participant
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
. 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, lithium and reserpine, within 6 months of Baseline Visit.
. 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.
. Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
. 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.
. 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.
. Conditions or medications that preclude safe performance of imaging procedures (MRI or DaTscan), including but not limited to severe claustrophobia, MRI-incompatible metal implants, or known hypersensitivity to imaging agents.