---
title: Studying safety of new tracer
nct_id: NCT07640542
phase: EARLY_PHASE1
status: RECRUITING
sponsor: MODAG GmbH
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07640542"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07640542"
last_fetched: "2026-07-31T14:00:13.181Z"
source: "Parkinson's Pathways (curated)"
---
# Studying safety of new tracer

**Goal (in five words):** Studying safety of new tracer

**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

**Trial ID:** [NCT07640542](https://clinicaltrials.gov/study/NCT07640542)

## Key Facts

- **Phase:** EARLY_PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** MODAG GmbH
- **Target Enrollment:** 9 participants
- **Start Date:** 2026-07-29
- **Completion Date:** 2027-07
- **Conditions:** Parkinson Disease (PD), MSA - Multiple System Atrophy, Healthy Adult Participants
- **Interventions:** [11C]MODAG-005
- **Intervention Types:** DRUG
- **Registry Record Last Updated:** 2026-07-31 (this month)

## 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.

**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.

## What This Actually Involves

**Placebo** _(From the protocol)_: Everyone in this trial receives the experimental treatment. There is no placebo group.

**Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period.

**Procedures** _(From the protocol)_:
- Injection (Minimally invasive)
  > "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."
- PET scan (Minimally invasive)
  > "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…"
- Heart tracing (ECG) (Non-invasive)
  > "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."

**Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long.

**Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered.

_Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._

## 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.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
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 \<90 or \>140 mmHg; diastolic blood pressure \<45 or \>90 mmHg; heart rate \<50 or \>95 beats per minute (BPM)
```

## Locations (1)

- Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare Bildgebung, Tübingen, Baden-Wurttemberg, Germany _(48.5227, 9.0522)_
  - Sibylle Braun-Lukaszewitz, PhD, (CONTACT), +49-7071-29-, sibylle.braun-lukaszewitz@med.uni-tuebingen.de
  - Christian La Fougère, MD, (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Johannes Levin, MD, (CONTACT), +49-6734-9622-8000, levin@modag.net

## 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.

---

*Canonical: https://parkinsonspathways.com/trial/NCT07640542*  
*HTML version: https://parkinsonspathways.com/trial/NCT07640542*  
*Source data: https://clinicaltrials.gov/study/NCT07640542*