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New treatment option for Tauopathies
Official title Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15
ClinicalTrials.gov ID: NCT06032026
What this study is testing
What is 11C-HY-2-15 PET?
11C-HY-2-15 PET is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tauopathies.
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
- The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA).
- 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 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- The entire cohort will include men and women clinically diagnosed with MSA, PD, PSP or are healthy controls. A sub-set of these participants who...
- Patients in all cohorts will be male or female adults from 40 to 80 years of age.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this...
- We will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study.
- Diagnosis-specific Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)
You likely can't join if
- Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to...
- Forms of parkinsonism other than PD, PSP and MSA as defined above
- Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
- History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
- Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or...
- Contraindication to MRI, such as non-compatible implanted medical device
See the full eligibility criteria
- The entire cohort will include men and women clinically diagnosed with MSA, PD, PSP or are healthy controls. A sub-set of these participants who undergo whole body scanning that will be used for analysis of...
- Patients in all cohorts will be male or female adults from 40 to 80 years of age.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to...
- We will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study.
- Diagnosis-specific Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)
- Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 11C HY-2-15, 11C-PiB or Florbetaben
- Forms of parkinsonism other than PD, PSP and MSA as defined above
- Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
- History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
- Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
- Contraindication to MRI, such as non-compatible implanted medical device
- PSP and MSA people will be excluded if they have a history of any prior positive ß-amyloid PET scan or positive CSF AD biomarkers.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 - 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, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.