Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age50-80
SponsorMODAG GmbH
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Enrolled in the PPMI 002 Clinical study as a healthy control participant
Any gender aged 50 to 75 years of age
Negative CSF α-synuclein seed amplification assay (SAA)
Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology.
Disqualifiers
Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease
Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit.
Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection, would render the participant unsuitable for the study enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
[¹⁸F]MODAG-009 PET imaging
DrugParticipants enrolled in the study will receive a single IV injection of \[¹⁸F\]MODAG-009 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with PD.
Time frame
Up to 3 hours after tracer injection.2
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with MSA.
Time frame
Up to 3 hours after tracer injection.3
Standard Uptake Value Ratios (SUVR)
To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in HC participants.
Time frame
Up to 3 hours after tracer injection.Secondary outcomes
1
Safety, tolerability, and feasibility
To assess the number and severity of adverse events following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame
From baseline to follow-up 2-3 business days after tracer injection.2
Safety, tolerability, and feasibility
To assess blood pressure \[mmHg\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame
From baseline to follow-up 2-3 business days after tracer injection.3
Safety, tolerability, and feasibility
To assess heart rate \[Hz\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame
From baseline to follow-up 2-3 business days after tracer injection.4
Safety, tolerability, and feasibility
To assess body temperature \[°C\] following administration of \[18F\]MODAG-009 tracer in human participants.
Time frame
From baseline to follow-up 2-3 business days after tracer injection.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MODAG GmbH
Lead sponsor
XingImaging, LLC
Collaborator
Institute for Neurodegenerative Disorders
Collaborator
Source ClinicalTrials.gov