An Early Phase 1 interventional study of C11-SY08 in Parkinson's Disease, Multiple System Atrophy and Dementia With Lewy Bodies, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Basic science
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:
An intravenous bolus injection of [11C]SY08 will be administered per subject for brain PET imaging.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Inclusion criteria, all subjects must:
Additional Inclusion criteria for PD patients, subjects must:
Additional Inclusion criteria for MSA patients, subjects must:
Additional Inclusion criteria for DLB patients, subjects must:
Exclusion Criteria:
General Exclusion Criteria (All Subjects)
General MR and PET safety exclusion criteria listed below
Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: C11-SY08
a PET imaging agent
brain uptake evaluation
The investigators will use SUV or SUV to evaluate brain uptake
Time frame: up tp 120 minutes
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.
Of 77 non-industry phase 1 interventional studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 68. This study's planned 30 months is below that.
Counting every sponsor, half of 204 studies reached it within 19 months; a quarter within 5 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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