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 range50 Years – 80 Years
SexALL
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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
✓. 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
✕. 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