89Zr-DFO-AP-101 Imaging for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging tracer, 89Zr-DFO-AP-101, to help diagnose and track ALS, a disease affecting nerve cells in the brain and spinal cord. The researchers aim to determine the tracer's safety and distribution in the body during PET scans. The study includes two groups: healthy individuals and those with ALS. Individuals diagnosed with ALS who experience difficulty moving or breathing, but can lie down for 45 minutes, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the new tracer works in people, offering participants the opportunity to be among the first to use this innovative diagnostic tool.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if 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 imaging technique is safe for ALS patients?
Research shows that the investigational imaging agent, 89Zr-DFO-AP-101, is safe and well-tolerated. In earlier studies with a similar compound, AP-101, used in patients with various types of ALS, safety goals were met, indicating it was generally well-received by patients. No serious side effects were reported, suggesting it does not cause significant harm.
This trial is in an early stage, so detailed safety information might be limited. However, the compound's success in passing safety checks in previous studies is encouraging. Participants in this trial will receive the treatment only once, reducing the risk of side effects. The safety record remains positive, but this study aims to gather more information.12345Why are researchers excited about this trial?
Unlike the standard treatments for ALS, which focus mainly on symptom management with medications like riluzole or edaravone, the new approach with 89Zr-DFO-AP-101 involves imaging. This treatment is unique because it uses a zirconium-89-labeled compound to potentially enhance the visualization of disease activity in the brain. Researchers are excited about this technique because it could provide better insights into the progression of ALS, helping to tailor treatments more effectively and possibly lead to new therapeutic strategies.
What evidence suggests that this imaging technique is effective for ALS?
Research has shown that the radiotracer 89Zr-DFO-AP-101 could help detect ALS early. In studies with mice, this tracer successfully identified the misfolded proteins associated with ALS. This could aid in diagnosing the disease sooner and monitoring its progression. In this trial, both healthy participants and patients with ALS will receive 89Zr-DFO-AP-101 to evaluate its effectiveness as an imaging tool for detecting changes in the brain and spinal cord of people with ALS. By using this tracer, doctors might detect the disease before symptoms become severe.45678
Who Is on the Research Team?
Eric E Turcotte, MD
Principal Investigator
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Brigitte Guérin, PhD
Principal Investigator
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Are You a Good Fit for This Trial?
This trial is for healthy adults over 50 and ALS patients aged 18 or older who can lie down for up to 45 minutes without help. Participants must not have other neurodegenerative diseases, severe psychiatric illnesses, recent blood transfusions, or be on certain respiratory support. Pregnant women and those not using contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of [89Zr]Zr-DFO-AP-101 and undergo PET/CT imaging
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 89Zr-DFO-AP-101
Trial Overview
The study tests a new PET scan radiotracer called [89Zr]Zr-DFO-AP-101 in both healthy volunteers and ALS patients to evaluate its safety and how it spreads throughout the body. This could potentially help in early detection of ALS.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.
Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Université de Sherbrooke
Lead Sponsor
Chorus Wellness Inc.
Industry Sponsor
AL-S Pharma AG
Collaborator
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Antibody-Based PET Imaging of Misfolded Superoxide ...
[ 89 Zr]Zr-DFO-α-miSOD1 PET can detect misSOD1 in transgenic mice, paving the way for application in early diagnosis of ALS and therapeutic monitoring.
Safety and Dosimetry of a New Radiotracer to Detect Misfolded ...
To that extent, the primary goal of this phase I study is evaluating the safety and biodistribution of the new tracer [89Zr]Zr-DFO-AP-101 in healthy volunteers ...
3.
ctv.veeva.com
ctv.veeva.com/study/safety-and-dosimetry-of-a-new-radiotracer-to-detect-misfolded-sod1-associated-with-amyotrophic-laterSafety and Dosimetry of a New Radiotracer to Detect Misfolded ...
The primary goal is evaluating the safety and biodistribution of the radiotracer [89Zr]Zr-DFO-AP-101 in healthy volunteers and ALS patients via PET/CT imaging.
AL-S Pharma announces positive topline results from ...
Phase 2 of AP-101 in sporadic ALS and mutant SOD1-ALS met its primary safety and tolerability endpoint. Clinically meaningful changes in ...
Trial | NCT05974579
The primary goal is evaluating the safety and biodistribution of the radiotracer \[89Zr\]Zr-DFO-AP-101 in healthy volunteers and ALS patients via PET/CT imaging ...
NCT05039099 | A Study to Evaluate, Safety, Tolerability ...
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
89Zr-DFO-AP-101 - Drug Targets, Indications, Patents
A Single Center, Open Label Study to Evaluate Biodistribution, Pharmacokinetics and Safety of [89Zr]Zr-DFO-AP-101 PET (Positron Emission Tomography) in ...
Antibody-Based PET Imaging of Misfolded Superoxide ...
[ 89 Zr]Zr-DFO-α-miSOD1 PET can detect misSOD1 in transgenic mice, paving the way for application in early diagnosis of ALS and therapeutic monitoring.
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