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
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Among 90 studies in Multiple System Atrophy with a site in United States — 21 open to participants now, 32 under way, 1 of them phase 3. Multiple System Atrophy · United States.
Among the 90 studies in Multiple System Atrophy with a site in United States, this one is the 43rd largest by planned enrollment of the 57 interventional ones that give a count, is one of 3 that started in 2026, is one of 18 in phase 1, reaches primary completion later than 16 of the 31 other live ones, and was the 88th registered.
207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.
Browse Multiple System Atrophy studies →21 of the 90 studies in Multiple System Atrophy with a site in United States are open now. Recruiting first, the newest first:
Prabesh Kanel · Sites in United States
Ages 45+
MODAG GmbH · Sites in United States
Ages 18–60 · Healthy volunteers
Teva Branded Pharmaceutical Products R&D LLC · Sites in United States, France, Germany and 4 more countries
Ages 30+
Tiziana Life Sciences LTD · Sites in United States
Ages 30–85
Craig van Horne, MD, PhD · Sites in United States
Ages 40–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Multiple System Atrophy studies recruiting now, 24 (42%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 18 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
90 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 20 · Phase 3 7 · Phase 4 2
First in 1995; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 13 is below the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.
Median enrollment 35 across the 57 interventional studies, 184 across the 31 observational. Of the 53 that completed or were terminated, 19 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 90 have an industry lead sponsor. The 10 most frequent:
MODAG GmbH is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
MODAG GmbH has 5 studies filed under Multiple System Atrophy — fewer than ten, so there is no comparison to draw.
19 of the studies in Multiple System Atrophy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT03042988Vanderbilt University Medical CenterOvernight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension | 2026-11-30 |
| NCT05167721Mayo ClinicRandomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy | 2026-12 |
| NCT02726711Vanderbilt UniversityReduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic | 2026-12 |
| NCT03312556Vanderbilt University Medical CenterTreatment of Supine Hypertension in Autonomic Failure (CPAP) | 2026-12-21 |
Add all 19 to your calendar (.ics) → With an account.
Among the 90 studies in Multiple System Atrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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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