PET Imaging Evaluation of [11C]SY08 (NCT06098612) | Clinical Trial Compass
RecruitingEarly Phase 1
PET Imaging Evaluation of [11C]SY08
United States40 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. A study partner who can answer questions pertaining to daily functioning
Exclusion criteria
. 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