Determining the half-life of SOD1 in the CSF
Washington University in St. Louis is seeking participants with ALS for a study to determine the half-life of the protein SOD1 in the cerebral spinal fluid
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Observational Study
Study Chair(s)/Principal Investigator(s):
Timothy Miller, MD, PhD, Washington University (St. Louis)
Clinicaltrials.gov ID (11 digit #):
Coordinating Center Contact InformationWashington University in St. Louis
660 S Euclid Ave.
St. Louis , Missouri 63110 United States
Full Study Summary:
Washington University in St. Louis is seeking participants with ALS for a study to determine the half-life of the protein SOD1 in the cerebral spinal fluid. Mutations in the SOD1 gene are known to cause some forms of familial ALS. Researchers are developing a treatment to reduce the level of SOD1 in familial ALS, but need to know more about how long SOD1 stays in the body (“half-life”) to help determine if the new treatment is effective. The study involves labeling or marking SOD1 with a special type of leucine. Leucine is an essential amino acid that is found in the foods we eat. In order to label the protein, participants undergo an overnight IV infusion. Following this labeling process, participants will then have 4-5 lumbar punctures (spinal taps) over a period of 3-4 months to collect spinal fluid from which the half-life of SOD1 can be measured. Each lumbar puncture visit takes approximately three hours.
Approximately 86 people will participate in this research study. There is no cost to participate. Participants will be paid up to $1775 for their time and effort. Reimbursement for travel and lodging will also be provided. The study is currently open to patients with a known SOD1 mutation as well as those with sporadic ALS.
Study Sponsor:ALS Finding A Cure/NIH
1 overnight stay for leucine infusion. 4-5 lumbar punctures performed over a period of 3-4 months at Washington University. Each lumbar puncture visit takes approximately three hours.