11C-HY-2-15 Radiotracer for Tauopathies
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool called 11C-HY-2-15, a radiotracer, to observe its distribution and behavior in the body and brain. The goal is to measure abnormal protein deposits in the brains of individuals with Multiple System Atrophy (MSA) and compare them to those with Parkinson's disease, progressive supranuclear palsy, and healthy individuals. Participants will undergo a special PET scan, and some may also have an MRI and other tests. This trial suits adults diagnosed with MSA, Parkinson's, or similar conditions, as well as healthy individuals interested in research participation. As an Early Phase 1 trial, this research focuses on understanding how the radiotracer functions in people, offering participants a chance to contribute to this innovative study.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this protocol is safe?
Research shows that 11C-HY-2-15, a new imaging agent, is under study for its ability to attach to certain brain proteins linked to diseases. Animal studies found that it enters the brain and exits quickly, suggesting safety due to its short duration in the body. However, as this trial is in its early stages, limited information exists about its safety in humans. Early trials often focus on understanding how the body processes the treatment. Although initial results are promising, further research is necessary to fully understand its safety in people.12345
Why are researchers excited about this trial?
Researchers are excited about the 11C-HY-2-15 radiotracer because it offers a new way to visualize tau protein deposits in the brain, which are associated with tauopathies like Alzheimer's disease. Unlike current treatments that primarily focus on alleviating symptoms or slowing progression, 11C-HY-2-15 provides a diagnostic edge by enabling more precise imaging of tau protein aggregates. This could lead to earlier and more accurate diagnosis, helping tailor treatment strategies to individual patients and potentially improving outcomes.
What evidence suggests that this radiotracer is effective for quantifying alpha-synuclein in tauopathies?
Studies have shown that the radiotracer 11C-HY-2-15, which participants in this trial will receive, effectively attaches to alpha-synuclein, a protein that clumps in the brains of people with conditions like Multiple System Atrophy (MSA). This radiotracer helps create images of these protein clumps using a PET scan, allowing doctors to see the location and amount of the protein in the brain. Research indicates that 11C-HY-2-15 concentrates more in certain brain areas, like the pallidum and midbrain, in patients with conditions such as Progressive Supranuclear Palsy (PSP). This suggests it might provide clear images of these protein deposits, aiding in better diagnosis and understanding of these diseases. Although studies in humans are still in the early stages, initial results are promising for its use in imaging alpha-synuclein in the brain.24678
Who Is on the Research Team?
Ilya Nasrallah, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Adults aged 40-80 with Multiple System Atrophy (MSA), Parkinson's disease (PD), progressive supranuclear palsy (PSP), or healthy volunteers can join. Participants must understand the study and consent, or have a partner to assist. Brain donation is optional for PD/MSA/PSP subjects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
PET Imaging
Participants undergo 11C-HY-2-15 PET scan to determine biodistribution, metabolism, excretion, and brain uptake. May include brain MRI and neurological assessments.
Follow-up
Participants are monitored for safety and effectiveness after PET imaging, including collection of adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- 11C-HY-2-15
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor