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PET Imaging Evaluation of [11C]SY08

PET Imaging Evaluation of [11C]SY08

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06098612
Enrollment
40
Registered
2023-10-24
Start date
2024-05-01
Completion date
2027-11-30
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGC11-SY08

a PET imaging agent

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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 functioning Additional Inclusion criteria for DLB patients, subjects must: 1. Have an existing diagnosis of probable DLB, using consensus criteria 2. Stable medications for at least 30 days 3. Clinical Dementia Rating Scale (CDR) \< 0.5 4. A study partner who can answer questions pertaining to daily functioning

Exclusion criteria

* General

Design outcomes

Primary

MeasureTime frameDescription
brain uptake evaluationup tp 120 minutesThe investigators will use SUV or SUV to evaluate brain uptake

Countries

United States

Contacts

Primary ContactChangning Wang, PhD
cwang15@mgh.harvard.edu6177243983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026