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

NCT07640542 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: MODAG-005-P1-012023-506965-72-00
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Parkinson Disease (PD); MSA - Multiple System Atrophy; Healthy Adult Participants

Keywords

MODAG; MODAG GmbH; Synuclein; Neurodegeneration; Lewy Body

Outcome Measures

Primary Outcomes (7)

• Safety and Tolerability

  AEs related to the medication

  Inclusion to 4 days (± 2 days) post injection.

• Safety and tolerability

  AEs leading to discontinuation/drop-out rates

  Inclusion to 4 days (± 2 days) post injection.

• Safety and tolerability

  SAEs related to the study medication.

  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.

  Inclusion to 4 days (± 2 days) post injection.

• Safety and tolerability

  Change in physical examination findings secondary to injection with \[11C\]MODAG-005.

  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.

  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

  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.

  Slots between 0 and 90 minutes after tracer injection.

• To assess the ability of [11C]MODAG-005 to discriminate between PD and HC

  Slots between 0 and 90 minutes after tracer injection.

• To assess the ability of [11C]MODAG-005 to discriminate between PD and MSA

  Slots between 0 and 90 minutes after tracer injection.

• To determine test-retest variability in PD and MSA under blocking conditions.

  8-49 days after first tracer injection.

Study Arms (1)

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.

Drug: [11C]MODAG-005

Interventions

[11C]MODAG-005 DRUG

Injection of \[11C\]MODAG-005 followed by PET imaging.

Parkinson´s Disease (PD), Multiple System Atrophy (MSA), Healthy controls (HC)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• MODAG GmbH: lead
• Universität Tübingen: collaborator
• ABX CRO: collaborator

MeSH Terms

Conditions

Parkinson Disease; Shy-Drager Syndrome; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Johannes Levin, MD

CONTACT

+49-6734-9622-8000; levin@modag.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share