Intermediate Expanded Access Protocol for ALS

This is an expanded access trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Gold, Nanoparticle, Expanded access, Au8, CNMAu8 Read More

Inclusion Criteria:

1. Able to understand and give written informed consent.
2. Male or female participants aged 18 years or greater (inclusive) at the time of ALS diagnosis.
3. Participants whose conditions are defined as "definite ALS" or "probable ALS" or "possible ALS" diagnostic criteria by the revised El Escorial Criteria as determined by a neurologist specializing in ALS (e.g., the Principal Investigator or subinvestigator at the site).
4. Participant is able to daily consume 60 mL of the investigational drug suspension without substantial dysphagia, OR can intake the drug through a gastrostomy tube.
5. In the judgement of the Investigator, the participant's expected survival is greater than six- months.
6. Participants who have established care with a neurologist at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP.

Exclusion Criteria:

1. Participant with a history of any clinically significant or unstable medical condition based on the Investigator's judgment that may interfere with assessment of the study objectives.
2. Based on the investigator's judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
3. Participant with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with EAP participation.

4. Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of

   • 500 eosinophils per microliter) at Screening.
5. Participants with a prior history of, or positive serological assay for the presence of HIV infection, or laboratory evidence of active or chronic infection with hepatitis C (HCV) or hepatitis B (HBV). Note, participants who have been vaccinated for HBV and have detectable HB antibodies are not excluded unless positive for surface antigen (HBsAg).
6. Participant has participated in any other investigational drug trial (within 4-weeks prior to screening or at least five-half lives of the investigational product), unless waived at the discretion of the Sponsor (e.g., for other investigational drug trials with no known interaction with CNM-Au8).
7. Females who are pregnant or nursing or who plan to get pregnant during the course of this clinical trial or within 6 months of the end of this trial.
8. Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
9. History of gold allergy.