18F-JSS20-183A for Tauopathies

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Alcohol abuse, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new PET scan treatment called 18F-JSS20-183A to study protein accumulation in the brains of individuals with neurodegenerative diseases such as Progressive Supranuclear Palsy (PSP) and Corticobasal Syndrome (CBS). The goal is to understand the distribution and spread of these proteins, which could improve diagnosis and comprehension of these conditions. Individuals diagnosed with PSP, CBS, Frontotemporal Lobar Degeneration, Parkinson's, Alzheimer's, or healthy controls may qualify if they have experienced related symptoms. Participants may undergo scans and neurological assessments as part of the study. As an Early Phase 1 trial, this research aims to understand how the treatment functions in people, offering participants a chance to contribute to groundbreaking discoveries.

Do I need to stop my current medications for the trial?

The trial protocol 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 18F-JSS20-183A remains in early testing stages. This compound, a radiotracer, is used in imaging to detect certain brain proteins linked to diseases like Alzheimer's and Parkinson's. The current focus is on understanding its processing in the body—how it spreads, breaks down, and is eliminated.

As this is an early-phase study, limited safety information is available. However, early studies aim to determine if the treatment is safe and well-tolerated, ensuring any side effects are minimal and manageable. It is important to note that this radiotracer is not yet approved, and researchers continue to learn about its effects in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-JSS20-183A PET for tauopathies because it offers a new way to visualize and understand tau protein build-up in the brain, which is a hallmark of diseases like Alzheimer's. Unlike existing treatments that primarily focus on symptom management, this PET scan aims to provide detailed imaging that can help in early diagnosis and monitoring of disease progression. By potentially offering a clearer picture of tau pathology, this method could lead to more targeted and effective treatments in the future.

What evidence suggests that 18F-JSS20-183A PET is effective for tauopathies?

Research has shown that 18F-JSS20-183A is a promising tool for PET scans, which are specialized brain images. It is designed to detect tau protein deposits in the brain. These proteins are linked to tauopathies, such as Progressive Supranuclear Palsy and Corticobasal Syndrome. Early results suggest that this tool detects these proteins more effectively in individuals with tau-related conditions than in healthy individuals. This capability may highlight abnormal protein buildup, providing important insights into these diseases. The trial aims to use this tool to enhance the understanding and diagnosis of tauopathies. Participants will undergo the 18F-JSS20-183A PET scan and may also have a brain MRI, an Amyloid PET scan, and neurological assessments. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with tauopathies like PSP, CBS, genetic FTLD, PD, AD or healthy controls. It aims to study a radiotracer's distribution and uptake in the brain. Participants will be recruited from multiple centers.

Inclusion Criteria

Investigators will ask disease cohort participants to agree to brain donation, but this choice is not mandatory for participation in this study

Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PSP-RS, CBS, Genetic FLTD, PD only)

I am between 40 and 85 years old.

Exclusion Criteria

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

Contraindication to MRI, such as non-compatible implanted medical device

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo 18F-JSS20-183A PET scan to determine biodistribution, metabolism, excretion, and brain uptake

4 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after PET imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-JSS20-183A PET

Trial Overview The study tests the biodistribution of 18F-JSS20-183A using PET scans, Brain MRI, Amyloid PET scans and neurological assessments to measure abnormal Tau protein deposits in various neurodegenerative diseases.

How Is the Trial Designed?

Group I: 18F-JSS20-183A PET Experimental Treatment 4 Interventions

Participants will undergo 18F-JSS20-183A PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study involving 14 patients with progressive supranuclear palsy (PSP), 18F-AV-1451 PET imaging revealed distinct subcortical binding patterns indicative of tau pathology, particularly in areas like the putamen and globus pallidus, compared to healthy controls.

However, the study found no correlation between the levels of 18F-AV-1451 binding and the severity of motor dysfunction in PSP patients, suggesting that this imaging technique may not be ideal for assessing tau pathology in relation to clinical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcortical 18 F-AV-1451 binding patterns in progressive supranuclear palsy. Cho, H., Choi, JY., Hwang, MS., et al.[2022]

The study found that the tau-binding radiotracer [18F]PI-2620 showed significantly higher uptake in the brains of Alzheimer's disease (AD) patients compared to cognitively normal individuals and those with mild cognitive impairment (MCI), indicating its potential as a diagnostic tool for differentiating AD from other cognitive states.

The analysis revealed specific brain regions, such as the occipital lobe and fusiform gyrus, where tau protein deposits were more pronounced in AD patients, aligning with known Braak Stages of tau pathology, which could help in identifying and understanding the progression of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evaluation of Tau Deposition with [18F]PI-2620 by Using a Semiquantitative Method in Cognitively Normal Subjects and Patients with Mild Cognitive Impairment and Alzheimer's Disease. Jantarato, A., Vachatimanont, S., Boonkawin, N., et al.[2021]

The study demonstrates that the PET tracer [18F]AV1451 effectively visualizes tau pathology in a patient with frontotemporal dementia (FTD) associated with the V337M MAPT mutation, indicating its potential as a diagnostic tool for this condition.

There is a strong correlation between the degree of [18F]AV1451 binding and the extent of tau pathology and brain atrophy, suggesting that this imaging technique can provide valuable insights into the progression of tau-related neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frontotemporal dementia with the V337M MAPT mutation: Tau-PET and pathology correlations. Spina, S., Schonhaut, DR., Boeve, BF., et al.[2022]

The PET imaging agent [18F]MK6240 effectively detects tau aggregates in the brain, showing a wide dynamic range of uptake in subjects with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), which aligns with known patterns of tau deposition.

While various quantification methods for [18F]MK6240 were tested, including compartmental and reference tissue models, caution is advised in using simplified methods for high binding cases due to potential underestimation of tau levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacokinetic modeling strategies for in-vivo quantification of tau with the radiotracer [18F]MK6240 in human subjects. Guehl, NJ., Wooten, DW., Yokell, DL., et al.[2023]

The PET tracer 18F-PI-2620 effectively detects tau pathology in Alzheimer's disease patients, showing significantly higher binding in brain regions associated with tau deposition compared to healthy controls, indicating its potential as a diagnostic tool.

The administration of 18F-PI-2620 was found to be safe and well tolerated, with imaging results demonstrating a strong correlation between tau uptake and cognitive impairment, suggesting its utility in assessing disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study. Mueller, A., Bullich, S., Barret, O., et al.[2022]

The tau-PET tracer [18F]PI-2620 effectively differentiates between 3/4-repeat tauopathies (like Alzheimer's disease) and 4-repeat tauopathies (such as corticobasal syndrome and progressive supranuclear palsy) based on binding characteristics observed in PET scans of 39 patients.

Patients with 4R tauopathies showed higher delivery and efflux rates of the tracer, indicating less stable binding compared to those with 3/4R tauopathies, which could help in better understanding and diagnosing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binding characteristics of [18F]PI-2620 distinguish the clinically predicted tau isoform in different tauopathies by PET. Song, M., Beyer, L., Kaiser, L., et al.[2022]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/d5fa8f6f9259e820/nct06932809-imaging-proteinopathies-pet-18f-jss20-183a

Study of Biodistribution, Metabolism, Excretion and ... - MedPath Determine whether there is selective uptake of 18F-JSS20-183A in people with taupathies compared to healthy volunteers and non-tau depositing neurodegenerative ...

2. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.4c02988

1H-indoles as Tauopathy Positron Emission Tomography ... Therefore, [18F]75 is a promising candidate for translation to human brain PET imaging studies with the potential to image tau aggregates not ...

3. withpower.com withpower.com/trial/18f-jss20-183a-for-tauopathies-da463

18F-JSS20-183A for Tauopathies 18F-JSS20-183A is a PET imaging agent specifically designed to visualize tau protein deposits in the brain, which are associated with tauopathies like ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40522652/

Frequency and Clinical Outcomes Associated With Tau ... Objective: To provide estimates of the frequency of tau PET positivity and its associated risk of clinical outcomes. ... tau Proteins* / analysis ...

5. sigma.larvol.com sigma.larvol.com/disease.php?DiseaseId=20633&tab=News&page=3

Progressive Supranuclear Palsy News The disease-specific spatial patterns of 18F-florzolotau positron emission tomography (PET) imaging exhibited high diagnostic accuracy in differentiating ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06932809

NCT06932809 | Study of Biodistribution, Metabolism ... The safety of 18F-JSS20-183A will also be evaluated in all participants. Some participants (usually those with positive 18F-JSS20-183A PET scan) may also be ...