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13 Participants NeededMy employer runs this trial

[¹⁸F]MODAG-009 PET Imaging for Parkinson's Disease

(MODAG-009-P1-0 Trial)

JL
Overseen ByJohannes Levin, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: MODAG GmbH
Must not be taking: Neuroleptics, Metoclopramide, Lithium, Reserpine
Disqualifiers: Alzheimer's, Psychiatric conditions, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single-center, open-label clinical study designed to evaluate the imaging characteristics and safety of \[¹⁸F\]MODAG-009 in participants with Parkinson's disease (PD), Multiple system atrophy (MSA), and Healthy controls (HC). Approximately 13 participants will be enrolled in this study. Each participant will receive a single intravenous injection of \[¹⁸F\]MODAG-009, followed by PET imaging using the investigational United Imaging NeuroEXPLORER (NX) camera.

Are You a Good Fit for This Trial?

This trial is for adults aged 50–80 who are already part of the PPMI study, including those with Parkinson's disease, multiple system atrophy, or healthy controls. Participants must have recent brain scans showing no major problems and meet certain memory and movement criteria.

Inclusion Criteria

Healthy Controls: Negative CSF α-synuclein seed amplification assay (SAA)
I am healthy and between 50 and 75 years old.
I have Parkinson's or early signs and a positive CSF SAA test.
See 13 more

Exclusion Criteria

All Cohorts: Any condition or abnormal labs that could interfere with safety of radiotracer injection or render participant unsuitable per investigator opinion
I do not have any condition that makes a lumbar puncture unsafe for me.
All Cohorts: Conditions or medications precluding safe imaging procedures including severe claustrophobia, MRI-incompatible metal implants, or known hypersensitivity to imaging agents
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single IV injection of [¹⁸F]MODAG-009 followed by PET imaging using the United Imaging NeuroEXPLORER (NX) camera for up to 3 hours post-injection.

1 day
1 visit (in-person)

Follow-up

Safety assessments including physical examination, vital signs, ECG, safety laboratory tests, and AE monitoring are conducted 2-3 business days after tracer injection.

2-3 days
1 contact (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

  • [¹⁸F]MODAG-009

Trial Overview

The study tests a new imaging agent called [¹⁸F]MODAG-009 used in PET scans to help visualize changes in the brain related to Parkinson’s disease and similar conditions. Each person gets one injection followed by a scan.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MODAG GmbH

Lead Sponsor

Trials
3
Recruited
190+

XingImaging, LLC

Industry Sponsor

Institute for Neurodegenerative Disorders

Collaborator

Trials
49
Recruited
13,000+

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