Parkinson's DiseaseEarly Phase 1NCT06098612
PET Imaging Evaluation of [11C]SY08
A Early Phase 1 study testing C11-SY08 in people with Parkinson's Disease and Multiple System Atrophy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Dementia With Lewy Bodies
- What is being tested?
- C11-SY08
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General Inclusion criteria, all subjects must:
- 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
- Additional Inclusion criteria for PD patients, subjects must:
Show all 20Show fewer
- 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
- Additional Inclusion criteria for MSA patients, subjects must:
- 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
- Additional Inclusion criteria for DLB patients, subjects must:
- Have an existing diagnosis of probable DLB, using consensus criteria
- Stable medications for at least 30 days
- Clinical Dementia Rating Scale (CDR) < 0.5
- A study partner who can answer questions pertaining to daily functioning
Who cannot join
- General Exclusion Criteria (All Subjects)
- 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
Show all 29Show fewer
- 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)
- General MR and PET safety exclusion criteria listed below
- 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
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
- Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
- Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential
- Body weight of > 300 lbs (weight limit of the MRI table)
- Breast feeding mothers
- Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan
- An abnormal result on the modified Allen's test on both hands
- Raynaud syndrome
- Bleeding disorder
- Use of anticoagulants such as Coumadin, Plavix or Lovenox
- An allergy to Lidocaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH
Charlestown, Massachusetts, 02129-2020
Changning Wang, 617-724-3983, cwang15@mgh.harvard.edu
About this study
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:
Read more
- To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals.
- To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA.
- 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.
- Being tested
- C11-SY08
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C11-SY08Drug
a PET imaging agent
| Study group | Role | What they receive |
|---|---|---|
| evaluation of alpha synuclein aggregates in the brain | Experimental | Not described Receives: Drug: C11-SY08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain uptake evaluation
The investigators will use SUV or SUV to evaluate brain uptake
Measured: up tp 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 May 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changning Wang, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098612
- Sponsor's protocol ID
- 2023P002302
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging Evaluation of [11C]SY08
- ClinicalTrials.gov ID
- NCT06098612
- Acronym / sponsor ID
- 2023P002302
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals.
- To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluation of alpha synuclein aggregates in the brain | Experimental | Drug: C11-SY08 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- General Inclusion criteria, all subjects must:
- 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
Key exclusion criteria (29 listed)
- General Exclusion Criteria (All Subjects)
- General MR and PET safety exclusion criteria listed below
- 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
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C11-SY08a PET imaging agent | Drug | evaluation of alpha synuclein aggregates in the brain |
Primary outcome
brain uptake evaluation
Time frame: up tp 120 minutes
The investigators will use SUV or SUV to evaluate brain uptake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Active, not recruitingPhase 2
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing C11-SY08 in people with Parkinson's Disease and Multiple System Atrophy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changning Wang, PhD (6177243983, cwang15@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain uptake evaluation (time frame: up tp 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.