A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

Brief Summary

Official Title: “A Multicenter Study for the Discovery and Validation of ALS Biomarkers”

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Detailed Clinical Trial Description

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

Outcome Measures for this Clinical Trial

Primary Measures

  • ALS Functional Rating Scale
    • Time Frame: Approximately every 4 months
      Safety Issue?: No
  • Vital Capacity (VC)
    • Time Frame: Approximately every 4 months
      Safety Issue?: No
  • Hand Held Dynamometry (HHD)
    • Time Frame: Approximately every 4 months
      Safety Issue?: No
  • Ashworth Spasticity Scale
    • Time Frame: Approximately every 4 months
      Safety Issue?: No
  • Fronto-Temporal Dementia (FTD) Assessment
    • Time Frame: Approximately every 4 months
      Safety Issue?: No
  • ALS Cognitive Behavioral Screen (ALS CBS)
    • Time Frame: Approximately every 4 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Age 18 or older
  • Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
  • Vital capacity (VC) at least 50 percent predicted
  • Able to undergo multiple lumbar punctures

Exclusion Criteria

  • Abnormal CSF pressure or intracranial/intraspinal tumors
  • Use of anticoagulant medication that cannot be safely withheld
  • Bleeding disorders
  • This is a partial listing.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • ALS Therapy Alliance
  • Provider of Information About this Clinical Study
    • Principal Investigator: James D. Berry MD, Principal Investigator – Massachusetts General Hospital
  • Overall Official(s)
    • James D. Berry, MD, MPH, Principal Investigator, Massachusetts General Hospital
  • Overall Contact(s)
    • Sylvia Baedorf Kassis, MPH, 617-643-5582, sbaedorfkassis@partners.org

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01495390