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RECRUITINGEARLY_PHASE1

PET Imaging Evaluation of [11C]SY08

NCT06098612•Massachusetts General Hospital

Summary

The overall goal of the proposed research is to evaluate the use of \[11C\]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. The purpose of this study is to evaluate the use of \[11C\]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are: 1. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. To determine human dosimetry of \[11C\]SY08 in healthy individuals An intravenous bolus injection of \[11C\]SY08 will be administered per subject for brain PET imaging.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
•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
•1. Have an existing diagnosis of MSA, using consensus criteria
•2. Stable medications for at least 30 days
+6 more criteria

Exclusion Criteria

•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
+16 more criteria

Locations (1)

MGH

Charlestown, Massachusetts, United States

Key Dates

Start Date

May 1, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Parkinson's DiseaseMultiple System AtrophyDementia With Lewy BodiesHealthy Controls

Interventions

C11-SY08

DRUG

Contacts

Changning Wang, PhD

CONTACT

6177243983 cwang15@mgh.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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PET Imaging Evaluation of [11C]SY08

Inclusion Criteria

Exclusion Criteria

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