Imaging Drugs for Progressive Supranuclear Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new imaging drugs, [18F]ABBV-964i and [18F]ABBV-965i, to help doctors detect brain changes related to Progressive Supranuclear Palsy (PSP), a disease affecting movement and thinking. Used with PET scans, these drugs aim to reveal where tau protein accumulates, which links to PSP and other brain diseases. The study evaluates the safety and effectiveness of the drugs in showing tau and examines their movement through the body. Adults who are healthy or have PSP and can undergo scans and medical tests may qualify for this trial. Participants will have PET scans, and some may also have MRI scans to aid researchers in developing better diagnostic tools for PSP. As an Early Phase 1 trial, this research focuses on understanding how these new imaging drugs work in people, offering participants a chance to contribute to groundbreaking PSP diagnostics.
Is there any evidence suggesting that these imaging drugs are likely to be safe for humans?
Research shows that the two new imaging drugs, [18F]ABBV-964i and [18F]ABBV-965i, are in the early stages of testing. Limited information is available about their safety in humans. The primary goal of this early testing is to determine the drugs' safety and how they function in the body. So far, the information primarily concerns these initial safety checks.
The FDA has not yet approved these drugs for any condition, making this study crucial to ensure their safety for people. Participants in the study will undergo PET scans and other tests to monitor for any side effects. Although specific data on potential side effects is not yet available, the study includes safety checks such as physical exams and lab tests to monitor participants' health during the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Progressive Supranuclear Palsy, [18F]ABBV-964i and [18F]ABBV-965i, because they offer a new way to visualize and understand the condition using PET imaging. Unlike traditional treatments that generally focus on symptom management, these imaging drugs aim to provide detailed insights into how the disease affects the brain. By targeting specific brain activity and structures, they might help identify changes earlier and more accurately than current methods. This could lead to better-targeted therapies in the future, potentially transforming how this challenging condition is managed.
What evidence suggests that these imaging drugs are effective for showing tau in the brain related to Progressive Supranuclear Palsy?
Research has shown that a buildup of tau protein in the brain links to Progressive Supranuclear Palsy (PSP). This trial studies the imaging drugs [18F]ABBV-964i and [18F]ABBV-965i for use with PET scans to detect tau in the brain. Previous studies have demonstrated that similar PET imaging methods can help diagnose PSP by highlighting tau protein accumulation, aiding doctors in observing brain changes related to PSP. Although these specific drugs are new, they function like other successful PET imaging drugs that identify tau buildup in PSP and other brain conditions. These findings suggest that [18F]ABBV-964i and [18F]ABBV-965i could serve as effective tools for better understanding and diagnosing PSP.16789
Are You a Good Fit for This Trial?
Adults who are healthy or have Progressive Supranuclear Palsy (PSP) may join. They must weigh between 43-120 kg and be able to lie still for imaging. Women should use two forms of contraception, while men also need to use protection and avoid sperm donation during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part A - Dosimetry
Healthy participants receive low-dose PET imaging to determine radiation dosimetry using both tracers
Part B - Proof of Concept
Participants receive PET imaging to evaluate tracer kinetics and brain uptake in PSP and healthy volunteers
Part C - Test-Retest (Optional)
Participants receive repeated brain PET scans to assess test-retest reproducibility of the selected tracer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [18F]ABBV-964i
- [18F]ABBV-965i
Trial Overview
The trial is testing [18F]ABBV-964i and [18F]ABBV-965i, new drugs used in PET scans to detect tau protein buildup in the brain associated with PSP. It evaluates safety, how well they work for imaging tau, their movement through the body, and radiation levels.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants receive two PET scans using the same drug to see if results are consistent.
Participants receive \[18F\]ABBV-964i and \[18F\]ABBV-965i for PET imaging to see how the drugs work in the brain.
Healthy participants receive \[18F\]ABBV-964i and \[18F\]ABBV-965i for PET imaging.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Invicro
Lead Sponsor
Enigma Biomedical USA
Collaborator
Citations
First-in-Human Study for the Safety and Evaluation of Two ...
This clinical study is being conducted to learn more about two new imaging drugs, called [18F]ABBV-964i and [18F]ABBV-965i, ...
18F-FDG, 18F-FP-CIT, and 18F-Florzolotau PET Imaging in ...
Materials and methods: Twenty-eight patients with clinically diagnosed PSP underwent 18F-FDG, 18F-FP-CIT, and 18F-Florzolotau PET imaging.
18F-PI-2620 Tau PET Improves the Imaging Diagnosis of ...
IMPLICATIONS FOR PATIENT CARE: 18F-PI-2620 PET appears to be a valuable biomarker in PSP and could be of value both for improving early clinical PSP diagnosis ...
(PDF) Improved interpretation of 18F-florzolotau PET in ...
The ¹⁸ F-Florzolotau staging systems were positively correlated with clinical severity as reflected by PSPrs scores. Conclusions ¹⁸ F-Florzolotau PET imaging ...
A Review of FDG-PET in Progressive Supranuclear Palsy ...
The findings showed that both imaging modalities were more effective at predicting the presence of specific clinical features rather than their severity ...
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ctv.veeva.com
ctv.veeva.com/study/first-in-human-study-for-the-safety-and-evaluation-of-two-4r-tau-ligands-as-potential-pet-radioliganFirst-in-Human Study for the Safety and Evaluation of Two 4R ...
This clinical study is being conducted to learn more about two new imaging drugs, called [18F]ABBV-964i and [18F]ABBV-965i, ...
Progressive Supranuclear Palsy Phase 2 Platform Clinical ...
In a completed 24-month Phase 2 study in Alzheimer's Disease, AADvac1 demonstrated a favorable safety profile, with therapeutic effects on ...
Paraneoplastic progressive Supranuclear palsy: a case report ...
Progressive supranuclear palsy-Richardson syndrome (PSP-RS) is a sporadic atypical parkinsonian disorder typically resistant to levodopa.
Study Details | NCT04539041 | Safety, Tolerability and ...
Safety assessments will include physical and neurological examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry ...
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