Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis

Prior treatment

• 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.
• Plan to have surgery or other invasive procedure during the course of the study (up to 14 days post-injection)
• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs and AP-101) within 3 months or 5 half-lives (whichever is longer) prior to study drug injection.
• Have received any blood or blood products within the 3 months prior to screening.

Lab values

• 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.
  • Have severe active psychiatric illness.
  • Have a diagnosis of another neurodegenerative disease (e.g. Parkinson disease, Alzheimer's disease, etc).
  • Have a significant infection or known inflammatory process on screening or at Day 0.
  • Alcohol or drug abuse based on patient auto-report
  • Have a history of relevant atopy or drug hypersensitivity or allergy to antibodies;
  • Have an abnormal blood pressure (supine) defined as a diastolic blood pressure \>90 or \<45 mmHg and/or a systolic blood pressure \>160 or \<90 mmHg. Re-testing may occur once during the screening visit within 2 hours of the initial abnormal blood pressure measurement at the discretion of the investigator.

Age

• 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.

Other

• For ALS patients:
  • Have undergone a tracheostomy for ALS symptoms.
  • Are on nasal intermittent positive pressure ventilation (NIPPV) \>4h during the day, while awake for the treatment of ALS related symptoms.
  • Have other causes of neuromuscular weakness.
• Cannot communicate reliably with the investigator.
• Are unwilling or unable to give written informed consent.
• In the opinion of the medical doctor or his/her delegate, are unsuitable for inclusion in the study.

• 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.