New PET tracer aims to spot Parkinson's in the brain
NCT ID NCT07640555
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new radioactive tracer called [¹⁸F]MODAG-009 to see if it can safely highlight abnormal protein clumps in the brains of people with Parkinson's disease or multiple system atrophy (MSA). About 13 participants, including healthy volunteers, will receive one injection and undergo a PET scan. The main goal is to measure where the tracer collects in the brain and check for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [¹⁸F]MODAG-009 (a radioactive tracer for PET imaging)
- What this could lead to
- If successful, this could lead to a new way to detect and distinguish Parkinson's disease and multiple system atrophy using brain scans.
- What could go wrong
- This is a very early, small study (13 people) focused on safety and imaging, not treatment. The tracer may not clearly show differences between groups or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy Controls inclusion criteria: 1. Enrolled in the PPMI 002 Clinical study as a healthy control participant 2. Any gender aged 50 to 75 years of age 3. Negative CSF α-synuclein seed amplification assay (SAA) 4. Previously acquired (since inclusion in PPMI) brain MRI without evidence of significant neurological pathology. 5. 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. 6. 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. * Parkinson's Disease and Prodromal PD inclusion criteria: 1. Enrolled in the PPMI 002 Clinical study as a Parkinson's Disease (PD) or Prodromal participant 2. Any gender aged 50 to 80 years of age 3. Positive CSF SAA 4. 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. 5. Montreal Cognitive Assessment (MoCA) greater than or equal to 24 at the last PPMI annual visit which was within the past 18 months. * Multiple System Atrophy (MSA) inclusion criteria: 1. Any gender aged 50 to 75 years of age 2. 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) 3. Positive CSF SAA 4. 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. 5. Evidence of nigrostriatal degeneration on DaTscan obtained at screening or on previously acquired imaging since the onset of the motor symptoms attributed to MSA. Exclusion Criteria: * All Cohorts: 1. Clinical evidence of other neurodegenerative diseases, such as Alzheimer's disease 2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 3. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide, lithium and reserpine, within 6 months of Baseline Visit. 4. 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. 5. Participation in an investigational drug trial targeting α-synuclein within the past 6 months prior to enrollment. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute for Neurodegenerative Disorders and XingImaging, LLC
RECRUITINGNew Haven, Connecticut, 06510, United States
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