An Early Phase 1 interventional study of [¹⁸F]MODAG-009 PET imaging in Multiple System Atrophy (MSA), Healthy Adult and Parkinson Disease, sponsored by MODAG GmbH. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by MODAG GmbH · Early Phase 1, Interventional, and Diagnostic
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 physical examination, vital signs, ECG, safety laboratory tests, and AE monitoring on the imaging day and at a follow-up contact 2-3 business days after tracer injection. Blood sampling is performed for radiometabolite analysis and to support quantitative interpretation of PET data, as specified in the IAP.
Approximately 13 participants will be enrolled in this study. All PD and HC participants will be enrolled from the ongoing PPMI 002 Clinical study at the INDD site. Leveraging the existing PPMI cohort allows use of previously collected clinical and biomarker data, thereby minimizing participant burden and ensuring alignment with established study assessments. The MSA cohort will be enrolled from the general population.
207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.
This study's planned enrollment of 13 is below the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.
Browse Multiple System Atrophy studies →MODAG GmbH is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy Controls inclusion criteria:
Parkinson's Disease and Prodromal PD inclusion criteria:
Multiple System Atrophy (MSA) inclusion criteria:
Exclusion Criteria:
All Cohorts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants enrolled in the study will receive a single IV injection of up to up to 8 mCi of \[¹⁸F\]MODAG-009.
Drug: [¹⁸F]MODAG-009 PET imaging
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.
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with PD.
Time frame: Up to 3 hours after tracer injection.
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with MSA.
Time frame: Up to 3 hours after tracer injection.
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in HC participants.
Time frame: Up to 3 hours after tracer injection.
Safety, tolerability, and feasibility
To assess the number and severity of adverse events following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess blood pressure \[mmHg\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess heart rate \[Hz\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess body temperature \[°C\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess the treatment-emergent changes in physical examination following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess changes the clinical laboratory tests including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess drop-out/early discontinuation following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Safety, tolerability, and feasibility
To assess 12-lead ECG parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF) following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame: From baseline to follow-up 2-3 business days after tracer injection.
Regional brain uptake
To determine regional brain uptake of \[¹⁸F\]MODAG-009 and binding patterns associated with α-synuclein pathology.
Time frame: Up to 3 hours after tracer injection.
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 25 phase 1 interventional studies under Multiple System Atrophy, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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