Actively Recruiting

Early Phase 1
Age: 50Years - 80Years
All Genders
Healthy Volunteers
NCT06098612

PET Imaging Evaluation of [11C]SY08

Led by Massachusetts General Hospital · Updated on 2025-12-24

40

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PET Imaging Evaluation of [11C]SY08

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 to 80 years
  • Able to provide written informed consent or assent
  • Able to read, speak, and understand English
  • Willing and able to participate in one PET/MRI scanning session
  • For Parkinson's disease patients: diagnosed with idiopathic PD using consensus criteria
  • For Parkinson's disease patients: stable medications for at least 30 days
  • For Parkinson's disease patients: Hoehn and Yahr stage I-IV
  • For Parkinson's disease patients: have a study partner who can answer questions about daily functioning
  • For Multiple System Atrophy patients: diagnosed with MSA using consensus criteria
  • For Multiple System Atrophy patients: stable medications for at least 30 days
  • For Multiple System Atrophy patients: classified as MSAp or MSAc
  • For Multiple System Atrophy patients: have a study partner who can answer questions about daily functioning
  • For Dementia with Lewy Bodies patients: diagnosed with probable DLB using consensus criteria
  • For Dementia with Lewy Bodies patients: stable medications for at least 30 days
  • For Dementia with Lewy Bodies patients: Clinical Dementia Rating Scale (CDR) less than 0.5
  • For Dementia with Lewy Bodies patients: have a study partner who can answer questions about daily functioning
Not Eligible

You will not qualify if you...

  • History of uncontrolled vascular risk factors such as hypertension or hyperlipidemia
  • Major psychiatric diseases like schizophrenia
  • History of stroke
  • Focal brain lesions visible on MRI scans
  • Major illnesses including significant kidney, liver, or neurological problems
  • Major surgery within the past 6 months
  • History of head trauma caused by external mechanical forces
  • Problems with urination unless managed
  • Past or present bipolar disorder or other Axis I diagnoses (treated depression allowed)
  • Current substance abuse including drugs or alcohol
  • Unable to lie flat on the camera bed for up to 90 minutes
  • Pregnancy or breastfeeding
  • Presence of metallic foreign bodies affected by MRI or severe claustrophobia
  • Recent radiation exposure exceeding limits when combined with this study
  • Ferromagnetic implants or objects such as aneurysm clips, prostheses, or metal fragments
  • Electrical implants like pacemakers or perfusion pumps
  • Medical conditions causing seizures, claustrophobia, or high risk of cardiac arrest
  • Body weight over 300 lbs (MRI table limit)
  • For women of childbearing potential, failure to have a negative pregnancy test on PET day
  • Breastfeeding mothers
  • For arterial line blood draws: abnormal modified Allen's test on both hands, Raynaud syndrome, bleeding disorders
  • Use of blood thinners such as Coumadin, Plavix, or Lovenox
  • Allergy to lidocaine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MGH

Charlestown, Massachusetts, United States, 02129-2020

Actively Recruiting

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Research Team

C

Changning Wang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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PET Imaging Evaluation of [11C]SY08 | DecenTrialz