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Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase
Sponsor: MODAG GmbH
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.
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
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2026-07-29
Completion Date
2027-07
Last Updated
2026-07-31
Healthy Volunteers
Yes
Interventions
[11C]MODAG-005
Injection of \[11C\]MODAG-005 followed by PET imaging.
Locations (1)
Radiologische Klinik, Universitätsklinikum Tübingen, Abt. Nuklearmedizin & Klinische Molekulare Bildgebung
Tübingen, Baden-Wurttemberg, Germany