Investigating a new radiotracer for brain tau protein in neurodegenerative diseases
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 18F-JSS20-183A
This study is testing a new imaging tool to see how well it can detect a specific brain protein linked to various neurodegenerative diseases in people who have these conditions and healthy individuals.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06932809 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the biodistribution, metabolism, excretion, and brain uptake of the radiotracer 18F-JSS20-183A, which is designed to quantify the 4Repeat Tau (4Rtau) protein associated with tauopathies. Participants will include individuals diagnosed with Progressive Supranuclear Palsy, Corticobasal Syndrome, genetic Frontotemporal Lobar Degeneration, Alzheimer's Disease, Parkinson's Disease, and healthy controls. The study will recruit up to 90 subjects across multiple sites, with a focus on understanding how this radiotracer behaves in the human body and its potential role in diagnosing and monitoring these neurodegenerative conditions. The University of Pennsylvania will lead the project, collaborating with several other prestigious institutions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40 to 85 with a diagnosis of tauopathies or healthy controls.
Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could enhance the ability to diagnose and monitor tauopathies, leading to better patient management and treatment strategies.
How similar studies have performed: Other studies utilizing similar radiotracers for imaging tau proteins have shown promise, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients in all cohorts will be male or female adults from 40 to 85 years of age. 2. 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 study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits. Investigators will ask disease cohort participants to agree to brain donation, but this choice is not mandatory for participation in this study. Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee (except AD and HC cohorts) for diagnostic agreement using video exams of each participant that are stored at WashU in a secured video repository with view-only access exclusively by secured virtual private network (VPN) connection. Video exam and screening assessments for PSP, CBS, MSA, PD, and FTLD may not be required to be repeated if they have been done within 6 months of enrollment, unless requested at the discretion of an investigator to document changes in clinical progression. A consensus committee will not be required to be repeated for participants who have already had a consensus committee diagnosis documented. Exclusion Criteria: 1. 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 18F-JSS20-183A 11C-PiB or 18F-Florbetaben 2. Forms of parkinsonism other than PSP-RS, and PD as defined above 3. History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported 4. Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician 5. Contraindication to MRI, such as non-compatible implanted medical device 6. 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 or successful participation in the study
Where this trial is running
San Francisco, California and 1 other locations
- University of California — San Francisco, California, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.