New PET tracer could spot Parkinson's protein in living brains
NCT ID NCT06098612
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new radioactive tracer called [11C]SY08 to see if it can detect clumps of alpha-synuclein protein in the brain using PET scans. Researchers will scan 40 volunteers, including healthy people and those with Parkinson's disease, multiple system atrophy, or dementia with Lewy bodies. The goal is to improve diagnosis and understanding of these brain diseases.
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * General Inclusion criteria, all subjects must: 1. Age 50-80 2. Be able to provide written informed consent or assent 3. Be able to read, speak and understand English (The investigators do not have the resources necessary to properly study non-English speaking patients in this study, given that translation and validation of the assessment tools would be necessary) 4. Be willing and able to participate in one PET/MRI scanning session Additional Inclusion criteria for PD patients, subjects must: 1. Have an existing diagnosis of idiopathic PD, using consensus criteria 2. Stable medications for at least 30 days 3. Hoehn and Yahr stage I-IV 4. A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for MSA patients, subjects must: 1. Have an existing diagnosis of MSA, using consensus criteria 2. Stable medications for at least 30 days 3. MSAp or MSAc 4. A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for DLB patients, subjects must: 1. Have an existing diagnosis of probable DLB, using consensus criteria 2. Stable medications for at least 30 days 3. Clinical Dementia Rating Scale (CDR) \< 0.5 4. A study partner who can answer questions pertaining to daily functioning Exclusion Criteria: * General Exclusion Criteria (All Subjects) 1. History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled 2. Major psychiatric disease (e.g.schizophrenia) 3. History of stroke 4. Focal brain lesions on MRI scans 5. History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness 6. Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months 7. History of head trauma (as defined as having any insults to the brain that may have resulted from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile) 8. Impaired elimination (as defined as having problems with urination) unless being managed 9. Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed) 10. Any present substance abuse including drug/alcohol abuse 11. Inability to lie flat on camera bed for up to 90 min 12. Pregnancy or breastfeeding 13. Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan 14. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts) General MR and PET safety exclusion criteria listed below 1. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing 2. Electrical implants such as cardiac pacemakers or perfusion pumps 3. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest 4. Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis) 5. Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential 6. Body weight of \> 300 lbs (weight limit of the MRI table) 7. Breast feeding mothers Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan 1. An abnormal result on the modified Allen's test on both hands 2. Raynaud syndrome 3. Bleeding disorder 4. Use of anticoagulants such as Coumadin, Plavix or Lovenox 5. An allergy to Lidocaine
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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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MGH
RECRUITINGCharlestown, Massachusetts, 02129-2020, United States
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