Who may be eligible for the Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase trial?

Inclusion Criteria: * Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC). Exclusion Criteria: 1. Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2. 2. Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator. 3. Clinically significant renal and hepatic dysfunction as judged by the investigator. 4. Known hypersensitivity to the active substance or to any of the excipients of \[11C\]MODAG-005 solution for injection. 5. Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules. 6. Participant has received an investigational drug within 3 months of screening. 7. Blood donations within 7 days before enrolment. 8. Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET/CT scan. 9. Unsuitable veins for repeated venipuncture. 10. Contraindication to blood sampling and/or arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be "abnormal" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments. 11. MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \>1 cm\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is \>20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants. 12. Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI. 13. Unwilling and/or unable to cooperate with trial procedures. Exclusion criteria for age-matched healthy controls: 14. Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin 15. Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN) 16. Systolic blood pressure \ 140 mmHg; diastolic blood pressure \ 90 mmHg; heart rate \ 95 beats per minute (BPM)

ClinicalTrials.gov record NCT07640542

Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase

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

An Open-label, Single-center Study to Evaluate the Safety and Test-retest Characteristics of [11C]MODAG-005 as PET Radioligand for Imaging Pathological Alpha-synuclein Deposition in the Brains of Patients With Parkinson's Disease (PD) or Multiple System Atrophy (MSA) Compared to Age-matched Healthy Controls (AMHC) - Pilot Phase

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 75 years old

SexAll

LocationGermany

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 open-label Phase 1 study evaluates the safety, tolerability, and test-retest characteristics of the investigational PET radioligand [11C]MODAG-005. People with Parkinson's disease or multiple system atrophy will receive PET/CT imaging; patients will have two scans 7–48 days apart and healthy controls will have one scan. A subset of patient participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to assess tracer uptake under blocking conditions.

What it is studying. The study is testing whether [11C]MODAG-005 is safe and tolerated and whether PET imaging with this tracer can distinguish MSA or PD from age-matched healthy controls, distinguish PD from MSA, and how consistent PET measurements are on repeat scans. Exploratory analyses include comparing tracer uptake with and without a single dose of anle138b and examining blood radioactivity/metabolite profiles and relationships between PET signal and clinical measures.

What the researchers hope to learn. Primary scientific goal: assess the safety and tolerability of [11C]MODAG-005. Secondary goals: evaluate whether PET with [11C]MODAG-005 can differentiate MSA from healthy controls, PD from healthy controls, and PD from MSA; and determine test-retest variability of PET measures. Exploratory goals: assess tracer uptake with and without anle138b blocking, measure blood radioactivity and metabolite profiles, derive image-based input functions, perform visual PET reads, and explore links between PET signal and clinical measures.

What this study is about

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

This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of [11C]MODAG-005, an investigational positron emission tomography/computed tomography (PET/CT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC). Participants with PD or MSA will undergo two [11C]MODAG-005 PET/CT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of [11C]MODAG-005. Secondary objectives include evaluating whether [11C]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.

Interventions being studied

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

Drug: [11C]MODAG-005

Eligibility

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

Inclusion criteria

Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC).

Exclusion criteria

Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2.
Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator.
Clinically significant renal and hepatic dysfunction as judged by the investigator.
Known hypersensitivity to the active substance or to any of the excipients of [11C]MODAG-005 solution for injection.
Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules.
Participant has received an investigational drug within 3 months of screening.
Blood donations within 7 days before enrolment.
Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET/CT scan.
Unsuitable veins for repeated venipuncture.
Contraindication to blood sampling and/or arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be "abnormal" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments.
MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1 cm\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is >20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants.
Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
Unwilling and/or unable to cooperate with trial procedures.
Exclusion criteria for age-matched healthy controls:
Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin
Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN)
Systolic blood pressure <90 or >140 mmHg; diastolic blood pressure <45 or >90 mmHg; heart rate <50 or >95 beats per minute (BPM)

Study description and what participation involves

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

Detailed description from the registry

This is an open-label, single-center Phase 1 study evaluating [11C]MODAG-005, an investigational Positron Emission Tomography (PET) radioligand for imaging pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC). Participants with PD or MSA will undergo two [11C]MODAG-005 PET/CT scans: a baseline scan and a follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline PET/CT scan. A subset of PD and MSA participants will receive a single oral dose of 300 mg anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of [11C]MODAG-005 based on adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms. Secondary objectives include evaluating whether [11C]MODAG-005 PET imaging can distinguish MSA from healthy controls, PD from healthy controls, and PD from MSA, and assessing test-retest variability of PET imaging measures. Exploratory analyses will assess tracer uptake with and without anle138b blocking, blood radioactivity and metabolite profiles, image-derived input functions, visual PET reads, and relationships between PET signal and clinical measures. Total study participation will last up to 12 weeks from screening to final follow-up.

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.

Participants undergo PET/CT imaging with an injection of the investigational radioligand [11C]MODAG-005 (people with PD or MSA have two scans: baseline and a follow‑up 7–48 days later; healthy controls have one baseline scan). A subset of PD and MSA participants will take a single oral 300 mg dose of anle138b (Emrusolmin) before the second scan. Study visits include MRI brain imaging, blood draws (including possible arterial blood sampling), vital signs, physical exams, laboratory tests and 12‑lead ECGs for safety monitoring. Total participation lasts up to about 12 weeks from screening to final follow‑up.

How the study is structured. Interventional, open-label, single-center, early-phase (Phase 1) study. Participants receive injections of the [11C]MODAG-005 radioligand followed by PET/CT imaging: PD and MSA participants receive two scans (baseline and a repeat 7–48 days later); healthy controls receive one baseline scan. A subset of PD and MSA participants receive a single oral 300 mg dose of anle138b (Emrusolmin) before their second scan to evaluate blocking. Safety monitoring includes recording adverse events, vital signs, physical exams, laboratory tests, and ECGs; total participation lasts up to about 12 weeks from screening to final follow-up.

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 Germany. 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: Jul 29, 2026
Primary completion: July 2027 (estimated)
Study completion: July 2027 (estimated)
Target enrollment: 9 participants (estimated)
Last updated on registry: Jul 31, 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: Universität Tübingen
ABX CRO

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 📞 +49-6734-9622-8000 ✉ levin@modag.net

Participating sites (1)

Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare BildgebungRecruiting
Tübingen, Baden-Wurttemberg · Germany
- Sibylle Braun-Lukaszewitz, PhD · +49-7071-29- ext. 83213 · sibylle.braun-lukaszewitz@med.uni-tuebingen.de
- Christian La Fougère, MD

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.
Phase 1 study: An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
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.
positron emission tomography: 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.
computed tomography: An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
primary objective: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
outcome measures: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
Key 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.
enrolment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Contraindication: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
at screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
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.
exclusion criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
adverse events: Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.

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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