At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Open Label Study to Evaluate Biodistribution, Pharmacokinetics and Safety of [89Zr]Zr-DFO-AP-101 PET (Positron Emission Tomography) in Healthy Volunteers and Amyotrophic Lateral Sclerosis (ALS) Patients
In Brief
A Phase 1 clinical trial evaluating 89Zr-DFO-AP-101 for Amyotrophic Lateral Sclerosis. Completed, enrolled 8 participants across 1 site.
Signals
Detailed Summary
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurodegenerative disease resulting in loss, primarily, of the motor neurons in the motor cortex, brainstem and spinal cord. It currently affects 3 of every 100,000 people in the US. Currently, there is no diagnostic tool for ALS, resulting in misdiagnosis and significant disease progression before formal diagnosis. An imaging test for early detection of ALS and for monitoring disease progression would have significant diagnostic and prognostic value. PET imaging with an appropriate radiotracer has great potential as a biomarker for ALS given that it would permit visualization of central nervous system (CNS) pathology in individuals living with the disease. 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 and ALS patients.
Study Details
Timeline
Arms & Interventions
Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.
Will receive 40MBq of 89Zr-DFO-AP-101, once, at Day 0.
Interventions
At Day 0, patients will receive one dose of the radiotracer. A PET/CT scan will be done 2h post-dose. At 1, 3, 7 and 10 days post-dose, a PET/CT scan will be repeated.