Determining the half-life of SOD1 in the CSF

Study Purpose:

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 Category:

Biomarkers/Imaging

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Timothy Miller, MD, PhD, Washington University (St. Louis)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

Washington University in St. Louis
Jennifer Balsarotti / .(JavaScript must be enabled to view this email address) / 314-362-6159
.(JavaScript must be enabled to view this email address) Dept. of Neurology, Campus Box 8111
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

Participant Duration:

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.

Estimated Enrollment:

86

Estimated Study Start Date:

12/01/2012

Estimated Study Completion Date:

10/01/2019

Posting Last Modified Date:

10/30/2017

Date Study Added to alsconsortium.org:

10/30/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


  • Site Contact Information

    Neurological Clinical Research Institute at Massachusetts General Hospital
    Dr. Katharine A. Nicholson, MD / .(JavaScript must be enabled to view this email address) / 617-743-0801
    165 Cambridge Street
    Boston, Massachusetts 20114
    United States