Who may be eligible for the Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies trial?

Inclusion Criteria: * 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: 1. Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant 2. Any gender aged 50 to 80 years of age 3. Positive CSF SAA 4. 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. 5. 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: 1. Any gender aged 50 to 75 years of age 2. 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) 3. Positive CSF SAA 4. 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. 5. Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA. Exclusion Criteria: * 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. 8. 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. 9. 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. 10. 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.

ClinicalTrials.gov record NCT07640555

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age50 years old to 80 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-group, open-label study will give one IV dose of [¹⁸F]MODAG-009 to about 13 people with Parkinson Disease, Multiple System Atrophy (MSA), or healthy controls. Participants have dynamic PET brain imaging for up to 3 hours after the injection, blood sampling, and safety checks, with a brief follow-up contact 2–3 business days later. Structural MRI (from prior studies or routine care) is used for anatomical localization.

What it is studying. The study is testing the imaging characteristics and short-term safety of the PET tracer [¹⁸F]MODAG-009 in people with Parkinson Disease, people with MSA, and healthy adults. It will measure brain uptake and standardized uptake value ratios (SUVR) up to three hours after injection and collect blood samples to help interpret the PET data.

What the researchers hope to learn. To evaluate brain uptake and regional binding patterns of [¹⁸F]MODAG-009 (including Standard Uptake Value Ratios) in Parkinson Disease, MSA, and healthy controls; to assess short-term safety, tolerability, and feasibility of the tracer; and to characterize binding patterns associated with α-synuclein pathology.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: [¹⁸F]MODAG-009 PET imaging

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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.
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.

Exclusion criteria

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.
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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

On a single study visit participants receive one intravenous injection of [¹⁸F]MODAG-009 and undergo dynamic brain PET imaging for up to three hours using the NeuroEXPLORER scanner. Blood samples are taken for radiometabolite analysis and safety laboratory testing; there are safety checks (physical exam, vital signs, ECG) on the imaging day and a follow-up contact 2–3 business days later. Participants must provide or allow use of prior brain MRI (and for MSA show DaTscan evidence) and may, if applicable, undergo a lumbar puncture; some medications may need to be temporarily held before imaging. The study uses previously collected PPMI data for PD and healthy control participants to limit extra testing when available.

How the study is structured. Interventional, early-phase 1, single-group open-label study. Each participant receives a single IV injection of the investigational tracer and then undergoes dynamic PET brain imaging for up to 3 hours. Safety assessments (vital signs, ECG, lab tests), blood sampling for radiometabolite analysis, and a 2–3 business day follow-up contact are included. No randomization or masking is used; structural MRI data are used for image localization when available.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 13, 2026
Primary completion: May 2027 (estimated)
Study completion: May 2027 (estimated)
Target enrollment: 13 participants (estimated)
Last updated on registry: Jun 10, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: MODAG GmbH
Collaborators: XingImaging, LLC
Institute for Neurodegenerative Disorders

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Johannes Levin, MD 📞 475-318-8250 (24 hours) ✉ Levin@modag.net

Participating sites (1)

Institute for Neurodegenerative Disorders and XingImaging, LLCRecruiting
New Haven, Connecticut, 06510 · United States
- Mackenzee George · 475-318-8250 (24 hours) · mgeorge@xingimaging.com
- Neha Prakash, MBBS

Terms used on this page · explanations by MedicalUpdates.ai

open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
PET: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
investigational: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
inclusion criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
at screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Lumbar puncture: A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
5 half-lives: The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
cohort: A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
biomarker: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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