Parkinson's Disease study: C11-SY08
Official title PET Imaging Evaluation of [11C]SY08
ClinicalTrials.gov ID: NCT06098612
What this study is testing
What is C11-SY08?
This is an investigational PET imaging agent being studied to help visualize specific protein clumps in the brains of people with Parkinson's disease and related conditions. is designed to bind to aggregated alpha-synuclein proteins in the brain so they can be seen on a PET scan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if a new substance can help brain scans detect specific protein clumps linked to Parkinson's and related conditions.
- Who it's for
- The study is looking for adults with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy Bodies, or healthy individuals.
- What's involved
- Participants will receive an injection of a special tracer into a vein and then undergo a PET scan (a type of brain imaging) to see how the tracer moves through the brain.
- Time commitment
- The study involves a single visit for the injection and brain scan.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join 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...
- Have an existing diagnosis of idiopathic PD, using consensus criteria
- Stable medications for at least 30 days
You likely can't join if
- General Exclusion Criteria (All people)
- 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
See the full eligibility 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...
- Have an existing diagnosis of idiopathic PD, using consensus criteria
- Stable medications for at least 30 days
- Hoehn and Yahr stage I-IV
- Have an existing diagnosis of MSA, using consensus criteria
- Stable medications for at least 30 days
- MSAp or MSAc
- 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
- General Exclusion Criteria (All people)
- 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...
- 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...
- 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 people 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
The study team makes the final eligibility decision.
Where it is enrolling
- Charlestown, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Charlestown, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.