PET Imaging Evaluation of [11C]SY08

NCT06098612 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2023P002302
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in healthy individuals.
2. 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. 3.To determine human dosimetry of \[11C\]SY08 in healthy individuals

Conditions

Parkinson's Disease; Multiple System Atrophy; Dementia With Lewy Bodies; Healthy Controls

Outcome Measures

Primary Outcomes (1)

• brain uptake evaluation

  The investigators will use SUV or SUV to evaluate brain uptake

  up tp 120 minutes

Study Arms (1)

evaluation of alpha synuclein aggregates in the brain

EXPERIMENTAL

Drug: C11-SY08

Interventions

C11-SY08 DRUG

a PET imaging agent

evaluation of alpha synuclein aggregates in the brain

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-80
• Be able to provide written informed consent or assent
• 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)
• Be willing and able to participate in one PET/MRI scanning session
• Have an existing diagnosis of idiopathic PD, using consensus criteria
• Stable medications for at least 30 days
• Hoehn and Yahr stage I-IV
• A study partner who can answer questions pertaining to daily functioning
• Have an existing diagnosis of MSA, using consensus criteria
• Stable medications for at least 30 days
• MSAp or MSAc
• A study partner who can answer questions pertaining to daily functioning
• Have an existing diagnosis of probable DLB, using consensus criteria
• Stable medications for at least 30 days
• Clinical Dementia Rating Scale (CDR) \< 0.5

You may not qualify if:

• History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled
• Major psychiatric disease (e.g.schizophrenia)
• History of stroke
• Focal brain lesions on MRI scans
• History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness
• Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months
• 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)
• Impaired elimination (as defined as having problems with urination) unless being managed
• Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed)
• Any present substance abuse including drug/alcohol abuse
• Inability to lie flat on camera bed for up to 90 min
• Pregnancy or breastfeeding
• 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
• Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts)
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH

Charlestown, Massachusetts, 02129-2020, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Changning Wang, PhD

CONTACT

6177243983; cwang15@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)