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

Study acronym: PIOSA
StatusRecruiting
PhaseEarly Phase 1
SponsorMODAG GmbH
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2026 to Jul 29, 2026
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07640542
Lead Sponsor MODAG GmbH
Collaborators: Universität Tübingen, ABX CRO
Conditions
(from sponsor)
Parkinson Disease (PD), MSA - Multiple System Atrophy, Healthy Adult Participants
Related terms Nerve Degeneration, Parkinson Disease, Shy-Drager Syndrome
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov