Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase (NCT07640542) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase
9 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using a new PET imaging agent called [11C]MODAG-005 that hasn't been widely tested in people yet — since it's an early Phase 1 study focused mainly on whether it's safe, what do we actually know so far about any risks of receiving this radioactive tracer?
2The trial is listed as 'not yet recruiting,' so how would we even find out when it opens, and is it worth waiting for it versus pursuing other diagnostic or treatment options now?
3Since this study includes people with Parkinson's disease, multiple system atrophy, and healthy volunteers, can you help me understand which group I might fall into and how that affects what the study would actually involve for me personally?
4The primary goal here seems to be testing the safety and reliability of this imaging tool rather than treating the disease itself — so what would I personally gain from participating, and are there any direct medical benefits or is this purely to help future patients?
5Given that this is a very early-phase pilot study, would taking part in it delay or interfere with starting any standard treatments for my condition that might already be available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
2
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
3
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
4
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
5
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
6
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
7
Safety and tolerability
Timeframe: Inclusion to 4 days (± 2 days) post injection.
. 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.