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Studies

Interventional Recruiting Early Phase 1

NCT07640542 on ClinicalTrials.gov

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

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

  • Sponsor: MODAG GmbH
  • Collaborators: Universität Tübingen, ABX CRO
  • Enrollment: 9 (Estimated)
  • Study start: 2026-07-29 (Actual)
  • Primary completion: 2027-07-01 (Estimated)
  • Study completion: 2027-07-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Diagnostic

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

Intervention / Treatment

  • Drug: [11C]MODAG-005

Primary Outcome Measures

  • Safety and Tolerability (Inclusion to 4 days (± 2 days) post injection.)
    AEs related to the medication
  • Safety and tolerability (Inclusion to 4 days (± 2 days) post injection.)
    AEs leading to discontinuation/drop-out rates
  • Safety and tolerability (Inclusion to 4 days (± 2 days) post injection.)
    SAEs related to the study medication.
  • Safety and tolerability (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 (Inclusion to 4 days (± 2 days) post injection.)
    Change in physical examination findings secondary to injection with \[11C\]MODAG-005.
  • Safety and tolerability (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 (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

Countries

Germany

Locations and Investigators

  • Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare Bildgebung, Tübingen, Germany (Recruiting)
    • Sibylle Braun-Lukaszewitz, PhD
    • Christian La Fougère, MD (Principal Investigator)