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Multiple System Atrophy (MSA)Early Phase 1MODAG-009-P1-0NCT07640555

Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies

A Early Phase 1 study testing [¹⁸F]MODAG-009 PET imaging in people with Multiple System Atrophy (MSA) and Healthy Adult, run by MODAG GmbH at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
What is being tested?
[¹⁸F]MODAG-009 PET imaging
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
13 May 2026to May 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • All Cohorts:
  • 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.
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  • 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.
  • Known hypersensitivity to DaTscan or iodine-containing compounds used as premedication for DaTscan. Participants with iodine sensitivity may still complete the imaging without iodine premedication at the investigator's discretion.
  • Use of medications known to interfere with DaTscan imaging (e.g., bupropion, amphetamines, methylphenidate, modafinil, alpha-methyldopa), unless the participant is willing and medically able to hold the medication for at least 5 half-lives or specified duration per investigators judgement prior to imaging.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Johannes Levin, MD contact

475-318-8250 (24 hours)

Levin@modag.net

United States1 site, 1 recruiting

  • Institute for Neurodegenerative Disorders and XingImaging, LLC

    New Haven, Connecticut, 06510

    Mackenzee George, 475-318-8250 (24 hours), mgeorge@xingimaging.com

    Neha Prakash, MBBS

    Recruiting

Other trials in United States

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.

Read the detailed description

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.

Being tested
[¹⁸F]MODAG-009 PET imaging
Keywords
MODAG, MODAG GmbH, MODAG-009, PET Tracer, Synuclein
Medical subject headings
Multiple System Atrophy, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [¹⁸F]MODAG-009 PET imagingDrug

    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.

Study groups in NCT07640555
Study groupRoleWhat they receive
Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)ExperimentalParticipants enrolled in the study will receive a single IV injection of up to up to 8 mCi of [¹⁸F]MODAG-009.
Receives: Drug: [¹⁸F]MODAG-009 PET imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Standard Uptake Value Ratios (SUVR)

    To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from [18F]MODAG-009 in participants with PD.

    Measured: Up to 3 hours after tracer injection.

  2. Standard Uptake Value Ratios (SUVR)

    To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from [18F]MODAG-009 in participants with MSA.

    Measured: Up to 3 hours after tracer injection.

  3. Standard Uptake Value Ratios (SUVR)

    To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from [18F]MODAG-009 in HC participants.

    Measured: Up to 3 hours after tracer injection.

Secondary outcomes (9)

  1. Safety, tolerability, and feasibility

    To assess the number and severity of adverse events following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  2. Safety, tolerability, and feasibility

    To assess blood pressure [mmHg] following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  3. Safety, tolerability, and feasibility

    To assess heart rate [Hz] following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  4. Safety, tolerability, and feasibility

    To assess body temperature [°C] following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  5. Safety, tolerability, and feasibility

    To assess the treatment-emergent changes in physical examination following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  6. 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.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  7. Safety, tolerability, and feasibility

    To assess drop-out/early discontinuation following administration of [18F]MODAG-009 tracer in human participants.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  8. 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.

    Measured: From baseline to follow-up 2-3 business days after tracer injection.

  9. Regional brain uptake

    To determine regional brain uptake of [¹⁸F]MODAG-009 and binding patterns associated with α-synuclein pathology.

    Measured: Up to 3 hours after tracer injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start13 May 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640555
Sponsor's protocol ID
MODAG-009-P1-01
Acronym
MODAG-009-P1-0
Status last verified
May 2026
First submitted
7 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [¹⁸F]MODAG-009 PET imaging in people with Multiple System Atrophy (MSA) and Healthy Adult, run by MODAG GmbH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Johannes Levin, MD (475-318-8250 (24 hours), Levin@modag.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard Uptake Value Ratios (SUVR) (time frame: Up to 3 hours after tracer injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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