Parkinson Disease (PD)Early Phase 1PIOSANCT07640542
Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase
A Early Phase 1 study testing [11C]MODAG-005 in people with Parkinson Disease (PD) and MSA - Multiple System Atrophy, run by MODAG GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD), MSA - Multiple System Atrophy, Healthy Adult Participants
- What is being tested?
- [11C]MODAG-005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jul 2026to Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare Bildgebung
Tübingen, Baden-Wurttemberg
Sibylle Braun-Lukaszewitz, PhD, +49-7071-29- ext. 83213, sibylle.braun-lukaszewitz@med.uni-tuebingen.de
Christian La Fougère, MD
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- [11C]MODAG-005
- Keywords
- MODAG, MODAG GmbH, Synuclein, Neurodegeneration, Lewy Body
- Medical subject headings
- Parkinson Disease, Shy-Drager Syndrome, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]MODAG-005Drug
Injection of [11C]MODAG-005 followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson´s Disease (PD), Multiple System Atrophy (MSA), Healthy controls (HC) | Experimental | Each participant with PD and each participant with MSA will receive two injections of up to 18 mL of [11C]MODAG-005 solution for injection with 40 - 400 MBq within 12 weeks. Each HC will receive one injection of up to 18 mL of [11C]MODAG-005 solution for injection with 40 - 400 MBq. Receives: Drug: [11C]MODAG-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
AEs related to the medication
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
AEs leading to discontinuation/drop-out rates
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
SAEs related to the study medication.
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in vital signs (heart rate [Hz], blood pressure [mmHg], body temperature[°C]) secondary to injection with [11C]MODAG-005.
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in physical examination findings secondary to injection with [11C]MODAG-005.
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Change in clinical laboratory results including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase secondary to injection with [11C]MODAG-005.
Measured: Inclusion to 4 days (± 2 days) post injection.
Safety and tolerability
Cahnge in 12-lead ECG parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF) secondary to injection with [11C]MODAG-005
Measured: Inclusion to 4 days (± 2 days) post injection.
Secondary outcomes (4)
To assess the ability of [11C]MODAG-005 to discriminate between MSA and HC.
Standardized uptake value ratio (SUVR) for different imaging time windows, volume of distribution (VT) and distribution volume ratio (DVR) in different brain regions between participants with MSA and AMHC from PET acquisitions after administration of [11C]MODAG-005.
Measured: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and HC
SUVR for different imaging time windows, VT, and DVRin different brain regions between patients with PD and AMHC from PET acquisitions after administration of [11C]MODAG-005.
Measured: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and MSA
SUVR for different imaging time windows, VT, and DVR in different brain regions between participants with PD and participants with MSA from PET acquisitions after administration of [11C]MODAG-005.
Measured: Slots between 0 and 90 minutes after tracer injection.
To determine test-retest variability in PD and MSA under blocking conditions.
Test-retest variability of SUVR for different time imaging time windows and DVR after administration of [11C]MODAG-005 in PD and MSA under blocking with a single dose of Emrusolmin 300 mg.
Measured: 8-49 days after first tracer injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start29 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MODAG GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universität Tübingen, ABX CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640542
- Sponsor's protocol ID
- MODAG-005-P1-01
- Other IDs
- 2023-506965-72-00, 2023
- Acronym
- PIOSA
- Status last verified
- Jul 2026
- First submitted
- 24 May 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07640542
- Acronym / sponsor ID
- PIOSA / MODAG-005-P1-01
- Keywords
- MODAG, MODAG GmbH, Synuclein, Neurodegeneration, Lewy Body
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- MODAG GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Universität Tübingen, ABX CRO
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson´s Disease (PD), Multiple System Atrophy (MSA), Healthy controls (HC) | Experimental | Drug: [11C]MODAG-005Each participant with PD and each participant with MSA will receive two injections of up to 18 mL of [11C]MODAG-005 solution for injection with 40 - 400 MBq within 12 weeks. Each HC will receive one injection of up to 18 mL of [11C]MODAG-005 solution for injection with 40 - 400 MBq. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]MODAG-005Injection of [11C]MODAG-005 followed by PET imaging. | Drug | Parkinson´s Disease (PD), Multiple System Atrophy (MSA), Healthy controls (HC) |
Primary outcome
Safety and Tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
AEs related to the medication
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
AEs leading to discontinuation/drop-out rates
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
SAEs related to the study medication.
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
Change in vital signs (heart rate [Hz], blood pressure [mmHg], body temperature[°C]) secondary to injection with [11C]MODAG-005.
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
Change in physical examination findings secondary to injection with [11C]MODAG-005.
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
Change in clinical laboratory results including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase secondary to injection with [11C]MODAG-005.
Safety and tolerability
Time frame: Inclusion to 4 days (± 2 days) post injection.
Cahnge in 12-lead ECG parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF) secondary to injection with [11C]MODAG-005
4 secondary outcomes
To assess the ability of [11C]MODAG-005 to discriminate between MSA and HC.
Time frame: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and HC
Time frame: Slots between 0 and 90 minutes after tracer injection.
To assess the ability of [11C]MODAG-005 to discriminate between PD and MSA
Time frame: Slots between 0 and 90 minutes after tracer injection.
To determine test-retest variability in PD and MSA under blocking conditions.
Time frame: 8-49 days after first tracer injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [11C]MODAG-005 in people with Parkinson Disease (PD) and MSA - Multiple System Atrophy, run by MODAG GmbH at 1 site in Germany.
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 1 inclusion and 16 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 31 Jul 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 Germany. 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 (+49-6734-9622-8000, levin@modag.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Inclusion to 4 days (± 2 days) post injection.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.