[11C]MODAG-005 for Parkinson's (NCT07640542)
Studying safety of new tracer
- Trial ID
- NCT07640542
- 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
- Goal
- Studying safety of new tracer
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- MODAG GmbH
- Study Type
- INTERVENTIONAL
- Enrollment
- 9 participants
- Conditions
- Parkinson Disease (PD), MSA - Multiple System Atrophy, Healthy Adult Participants
- Interventions
- [11C]MODAG-005
- Registry Record Last Updated
- 2026-07-31 (this month)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: injections, infusions, or blood draws). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
Goal: The aim of this early-phase 1 study is to check the safety, tolerability, and how consistent repeat scans are for a new PET imaging tracer called MODAG-005 that is intended to show abnormal alpha-synuclein, a brain protein linked to Parkinson's and multiple system atrophy. Approach: People with Parkinson's or multiple system atrophy will have two PET/CT brain scans (baseline and again 7 to 48 days later), while age-matched healthy volunteers have one baseline scan; a subset of PD and MSA participants will take a single oral dose of a medication called anle138b (Emrusolmin) before the second scan to see how that changes tracer uptake. Safety will be assessed with monitoring for side effects, vital signs, physical exams, lab tests, and heart tracings. Eligibility: Adults aged 50 to 75 with clinically established Parkinson's disease or clinically established/probable multiple system atrophy, or age-matched healthy adults, may join; people with significant unstable medical problems, certain abnormal lab results, or who are pregnant or breastfeeding are excluded.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Healthy volunteers: Also accepts people without Parkinson's (healthy volunteers) (criteria text: "CT.gov structured field: healthyVolunteers")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 50 to 75.
Locations
- Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare Bildgebung, Tübingen, Baden-Wurttemberg, Germany
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07640542. It is the one about "Studying safety of new tracer". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: Everyone in this trial receives the experimental treatment. There is no placebo group. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [11C]MODAG-005. Goal: The aim of this early-phase 1 study is to check the safety, tolerability, and how consistent repeat scans are for a new PET imaging tracer called MODAG-005 that is intended to show abnormal alpha-synuclein, a brain protein linked to Parkinson's and multiple system atrophy. Approach: People with Parkinson's or multiple system atrophy will have two PET/CT brain scans (baseline and again 7 to 48 days later), while age-matched healthy volunteers have one baseline scan; a subset of PD and MSA participants will take a single oral dose of a medication called anle138b (Emrusolmin) before the second scan to see how that changes tracer uptake. Safety will be assessed with monitoring for side effects, vital signs, physical exams, lab tests, and heart tracings. Eligibility: Adults aged 50 to 75 with clinically established Parkinson's disease or clinically established/probable multiple system atrophy, or age-matched healthy adults, may join; people with significant unstable medical problems, certain abnormal lab results, or who are pregnant or breastfeeding are excluded.
- Who can participate?
- Participants must be between 50 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive); PET scan (minimally invasive); Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.