| | NEALS CLINICAL RESEARCH STUDY
| | | | A Multicenter Study for the Validation of ALS Biomarkers | | | | Protocol #: BIO_ALS-01 Recruitment Status: Currently Recruiting Sponsor and Collaborators:
Massachusetts General Hospital
ALS Association Estimated Enrollment: 600 Study Start Date: April 2008 Detailed Description: Across the US, 21 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. Sponsored by the ALS Association and working in conjunction with Metabolon, Inc., blood and cerebrospinal fluid (CSF) is collected for metabolomic testing. Additionally, 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. All samples will be stored in the NEALS Sample Repository for use by ALS researchers. A total of 600 plasma and 210 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. 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 and neurological disease control groups. Healthy control enrollment is closed. Eligibility: Ages Eligible for Study: | 30 Years to 80 Years | Genders Eligible for Study: | Both | Accepts Healthy Volunteers: | Yes | Sampling Method: | Non-Probability Sample |
Contacts and/or Locations Link: Daniela Grasso, Project Manager
617-726-0842
dgrasso@partners.org Clinical Trials Information Line
1-877-458-0631 Patients may contact individual Study Coordinators at participating sites. Contact information for recruiting sites is listed below or can also be found on clinicaltrials.gov : http://www.clinicaltrials.gov/ct2/show/NCT00677768?term=biomarkers+als&rank=1 Massachusetts General Hospital, Site 701 Merit Cudkowicz, MD, MSc
Role: Co-Investigator
Massachusetts General Hospital
149 13th Street CNY, Room 2274
Charlestown, MA 02129
Work phone: 617-724-1873
Fax number: 617-724-7290
Email: mcudkowicz@partners.org Swati Aggarwal, MD
Role: Co-Investigator
Massachusetts General Hospital
149 13th Street CNY, Room 2274
Charlestown, MA 02129
Work phone: 617-726-5097
Fax number: 617-724-7290
Email: spaggarwal@partners.org Matt Jaffa
Role: Coordinator
Massachusetts General Hospital
149 13th Street CNY, Room 2274
Charlestown, MA 02129
Work phone:
Fax number: 617-724-7290
Email: mjaffa@partners.org Dartmouth Hitchcock Medical Center, Site 709 Brent Harris, MD
Role: Investigator/Coordinator
Department of Pathology
Dartmouth Medical School
One Medical Center Drive, DHMC
Lebanon, NH 03756
Work phone: 603-650-0889
Fax number: 603-650-6120
Email: bharris@dartmouth.edu Duke University Medical Center, Site 710 Richard Bedlack, MD
Role: Investigator
Neuroscience Clinical Research Organization
Duke University Medical Center
932 Morreene Road, Room 213
Durham, NC 27705
Work phone: 919-668-2639
Fax number: 919-668-2840
Email: bedla001@mc.duke.edu Karen Grace, RN
Role: Coordinator
Neuroscience Clinical Research Organization
Duke University Medical Center
932 Morreene Road, Room 213
Durham, NC 27705
Work phone: 919-668-2844
Fax number: 919-668-2840
Email: karen.grace@duke.edu Emory University, Site 711 Jonathan Glass, MD
Role: Investigator
The ALS Center at Emory University
101 Woodruff Circle, Suite 6000
Atlanta, GA 30322
Mail Stop: 1930-001-1AN
Work phone: 404-727-3507
Fax number: 404-778-3495
Email: jglas03@emory.edu Meraida Polak, RN
Role: Coordinator
The ALS Center at Emory University
101 Woodruff Circle, Suite 6000
Atlanta, GA 30322
Mail Stop: 1930-001-1AN
Work phone: 404-778-3807
Fax number: 919-668-2840
Email: mpolak@emory.edu Crystal Richards
Role: Co-Coordinator
The ALS Center at Emory University
101 Woodruff Circle, Suite 6000
Atlanta, GA 30322
Mail Stop: 1930-001-1AN
Work phone: 404-727-3813
Fax number: 919-668-2840
Email: cricha6@emory.edu Johns Hopkins University, Site 713 Nicholas Maragakis, MD
Role: Investigator
Johns Hopkins University - ALS Clinic
601 N. Caroline Street
Neurology, 5th Floor, Suite 5070
Baltimore, MD 21205
Work phone: 410-614-9874
Fax number: 410-614-4345
Email: nmaragak@jhmi.edu
Elizabeth (Betsy) Mosmiller
Role: Coordinator
Johns Hopkins University
1550 Orleans Street, 3M South
Baltimore, MD 21231
Work phone: 410-502-0495
Fax number: 410-502-7869
Email: emosmil1@jhmi.edu Lahey Clinic, Site 714 James Russell, DO
Role: Investigator
Lahey Clinic
Clinical Research
31 Mall Road
Burlington, MA 01805
Work phone: 781-744-8632
Fax number: 781-744-3772
Email: james.a.russell@lahey.org Stephanie Scala
Role: Coordinator
Lahey Clinic
Clinical Research
31 Mall Road
Burlington, MA 01805
Work phone: 781-744-2950
Fax number: 781-744-3772
Email: stephanie.a.scala@lahey.org Drexel University College of Medicine, Site 715 Terry Heiman-Patterson, MD
Role: Investigator
Drexel University College of Medicine
219 North Broad Street
7th Floor, Department of Neurology
Philadelphia, PA 19107
Work phone: 215-762-7692
Fax number: 215-762-3899
Email: terry.heiman-patterson@drexelmed.edu Christine Barr, RN
Role: Coordinator
Drexel University College of Medicine
219 North Broad Street
7th Floor, Department of Neurology
Philadelphia, PA 19107
Work phone: 215-762-5186
Fax number: 215-762-3899
Email: christine.barr@drexelmed.edu SUNY Upstate Medical University, Site 721 Jeremy Shefner, MD
Role: Investigator
Institute for Human Performance
Clinical Research Unit
505 Irving Avenue
Syracuse, NY 13210
Work phone: 315-464-5302
Fax number: 315-464-5303
Email: shefnerj@upstate.edu Mary Lou Watson, RRT
Role: Coordinator
Institute for Human Performance
Clinical Research Unit
505 Irving Avenue
Syracuse, NY 13210
Work phone: 315-464-5004
Fax number: 315-464-5303
Email: watsonm@upstate.edu | |
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