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Recruiting EARLY_Phase 1 NCT06098612

PET Imaging Evaluation of [11C]SY08

Trial Parameters

Condition Parkinson's Disease
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 40
Sex ALL
Min Age 50 Years
Max Age 80 Years
Start Date 2024-05-01
Completion 2026-11
Interventions
C11-SY08

Brief 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 Criteria

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 functionin

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