Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies

NCT07640555 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: MODAG-009-P1-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple System Atrophy (MSA); Healthy Adult; Parkinson Disease

Keywords

MODAG; MODAG GmbH; MODAG-009; PET Tracer; Synuclein

Outcome Measures

Primary Outcomes (3)

• Standard Uptake Value Ratios (SUVR)

  To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with PD.

  Up to 3 hours after tracer injection.

• Standard Uptake Value Ratios (SUVR)

  To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in participants with MSA.

  Up to 3 hours after tracer injection.

• Standard Uptake Value Ratios (SUVR)

  To evaluate Standard Uptake Value Ratios (SUVR) in brain regions from \[18F\]MODAG-009 in HC participants.

  Up to 3 hours after tracer injection.

Secondary Outcomes (9)

• Safety, tolerability, and feasibility

  From baseline to follow-up 2-3 business days after tracer injection.

• Safety, tolerability, and feasibility

  From baseline to follow-up 2-3 business days after tracer injection.

• Safety, tolerability, and feasibility

  From baseline to follow-up 2-3 business days after tracer injection.

• Safety, tolerability, and feasibility

  From baseline to follow-up 2-3 business days after tracer injection.

• Safety, tolerability, and feasibility

  From baseline to follow-up 2-3 business days after tracer injection.

Study Arms (1)

Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)

EXPERIMENTAL

Participants enrolled in the study will receive a single IV injection of up to up to 8 mCi of \[¹⁸F\]MODAG-009.

Drug: [¹⁸F]MODAG-009 PET imaging

Interventions

[¹⁸F]MODAG-009 PET imaging DRUG

Participants 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.

Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) score of \<6 at the last PPMI annual visit which is within the past 18 months.
• Cognitively intact with Montreal Cognitive Assessment (MoCA) greater than or equal to 26 at the last PPMI annual visit which was within the past 18 months.
• Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant
• Any gender aged 50 to 80 years of age
• Positive CSF SAA
• A current or previously acquired brain MRI (since the onset of motor symptoms for PD or since enrolled in PPMI for the prodromal PD) without evidence of significant neurological pathology other than changes expected for PD.
• Montreal Cognitive Assessment (MoCA) greater than or equal to 24 at the last PPMI annual visit which was within the past 18 months.
• Any gender aged 50 to 75 years of age
• Clinically established MSA or Clinically Probable MSA according to the Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy (Wenning et al., 2022)
• Positive CSF SAA
• A current or previously acquired brain MRI (since the onset of motor symptoms attributed to MSA) without evidence of significant neurological pathology other than the pathology expected for MSA.
• Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA.

You may not qualify if:

• All Cohorts:
• 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.
• Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment.
• Currently being treated with and unable to safely hold antiplatelets (other than low dose aspirin up to 100mg/day) or anticoagulants prior to the procedure that might preclude safe attempt of Lumbar puncture, if applicable.
• Condition that precludes the safe performance of routine lumbar puncture, if applicable, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant and uncorrected coagulopathy or thrombocytopenia.
• Conditions or medications that preclude safe performance of imaging procedures (MRI or DaTscan), including but not limited to severe claustrophobia, MRI-incompatible metal implants, or known hypersensitivity to imaging agents.
• Known hypersensitivity to DaTscan or iodine-containing compounds used as premedication for DaTscan. Participants with iodine sensitivity may still complete the imaging without iodine premedication at the investigator's discretion.
• Use of medications known to interfere with DaTscan imaging (e.g., bupropion, amphetamines, methylphenidate, modafinil, alpha-methyldopa), unless the participant is willing and medically able to hold the medication for at least 5 half-lives or specified duration per investigators judgement prior to imaging.

Sponsors & Collaborators

• MODAG GmbH: lead
• XingImaging, LLC: collaborator
• Institute for Neurodegenerative Disorders: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders and XingImaging, LLC

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders

Central Study Contacts

Johannes Levin, MD

CONTACT

475-318-8250 (24 hours); Levin@modag.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 10, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Locations

US (1)