Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alector Inc.
This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with C9orf72-associated Amyotrophic Lateral Sclerosis.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmation of C9orf72 mutation
Diagnosis of ALS by revised El Escorial criteria
Time since onset of muscle weakness due to ALS ≤36 months at the time of the Screening Visit
Slow Vital Capacity (VC) ≥50% of predicted capacity at the time of the Screening Visit
If taking riluzole, must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole naive participants are allowed.
If taking edaravone, must have completed at least one cycle of edaravone prior to the Screening Visit and plan to continue edaravone during the study. Edaravone naive participants are allowed.
Females must not be pregnant, breastfeeding or planning to conceive within the study period. Males must agree to use acceptable contraception
Capable of providing informed consent at the Screening visit and complying with study procedures throughout the study
You may not be if
Clinically significant, unstable, medical condition (other than ALS)
Clinically significant heart disease, liver disease or kidney disease
Cognitive impairment or dementia
Current uncontrolled hypertension
History of unresolved cancer
Any experimental gene therapy
Any experimental vaccine (any vaccine against COVID-19 either approved or administered under an Emergency Use Authorization is allowed)
