Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic La… (NCT05974579) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis
Canada12 participantsStarted 2023-11-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged of:
✓. For healthy participants: Male or female subjects aged 50 years or older
✓. For ALS patients: Male or female subjects aged 18 years and older
✓. Able to remain in a lying position for up to 45 minutes without respiratory support.
✓. A) For ALS patients, confirmed diagnostic of definitive ALS according to El-Escorial criteria14 B) for healthy participants: no neurologic condition (confirmed by physical exam)
✓. Have venous access sufficient to allow for blood sampling
✓. Are reliable and willing to make themselves available for the duration of the study and are willing to follow CRCHUS-specific study procedures.
Exclusion criteria
✕. Are currently enrolled or were enrolled in the last 12 weeks in any other clinical trial involving a study drug or off label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: day 0 (post-injection) to day 14 (end of study)
2
Biodistribution of [89Zr]Zr-DFO-AP-101
Timeframe: Pre-dose and at 2 hours, 1, 3, 7, 10 days post-dose
3
Dosimetry of [89Zr]Zr-DFO-AP-101 in human
Timeframe: Pre-Dose and at 2 hours, 1, 3, 7, 10 days post-dose
. Female participants who are pregnant or breast feeding; or women of childbearing potential (\<50 years old) and men who are sexually active who are not willing to use an accepted effective contraceptive method.
✕. Plan to have surgery or other invasive procedure during the course of the study (up to 14 days post-injection)
✕. Have a progressive medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality at screening and at first visit (D0) that, in the judgment of the medical doctor, indicate a medical problem that would preclude study participation.
✕. Have one of these conditions (for both patient groups):
✕. hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities (ALT or AST ≥3 × ULN or total bilirubin ≥2 × ULN) and hematology abnormalities at screening.
✕. severe chronic kidney disease (eg, an estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73m or requires chronic dialysis) at screening.