Protocol #: BIO_ALS-01
Recruitment Status: Currently Recruiting
Sponsor(s) and Collaborators: Massachusetts General Hospital, ALS Association (ALSA), ALS Therapy Alliance (ATA), National Institutes of Health (NIH)
Estimated Enrollment: 650
Study Start Date: April 2008
Detailed Description: Across the US and Canada, approximately 30 Northeast ALS Consortium (NEALS) ALS centers are currently participating in the study titled A Multicenter Study for the Validation of ALS Biomarkers with the primary objective of identifying factors that contribute to the pathogenesis of amyotrophic lateral sclerosis.
A total of 650 blood and 300 cerebrospinal fluid (CSF) samples will be collected from age and gender matched healthy individuals, disease mimics and ALS patients at a screening/baseline visit and again from ALS patients at months 6, 12, and 18. These samples will be stored in the NEALS Sample Repository for us by ALS researchers.
The study is sponsored by the ALS Association (ALSA) and the National Institutes of Health (NIH).
Additionally, funding by the ALS Therapy Alliance (ATA) and in collaboration with researchers at UMASS Worcester, Duke University and Penn State University, DNA will be collected from these same volunteers, extracted and analyzed for HFE genotyping. These DNA samples will also be used as part of a validation/replication study in ALS.
Patients with ALS (early and suspected) are also invited to participate in a data validation study with Patients Like ME. Clinical information collected at the study visit, such as ALSFRS-R, concomitant medications and medical history, will be compared to information that is self-reported on the website.
Volunteers must be at least 30 years of age, be able to answer brief questions about their medical and family history, and be willing to have blood and/or CSF drawn for the study. The study is currently open to enrollment to the early ALS, suspected ALS, neurological disease control and healthy control groups.
Eligibility:
Ages Eligible for Study: 30 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Locations & Contact Information:
Patients: Please Click HERE for a complete list of participating sites.
Patients may contact individual study coordinators at the participating sites directly.
Coordinating Center Contact Information:
Daniela Grasso, Project Manager
617-726-0842
dgrasso@partners.org
Clinical Trials Information Line
1-877-458-0631
For more information on this study please visit: http://www.clinicaltrials.gov/ct2/show/NCT00677768?term=biomarkers+als&rank=1
