ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): Study methodology, recruitment, and baseline demographic and disease characteristics

Abstract

In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods utilize an extensive structured telephone interview ascertaining environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3–6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Three hundred and fifty-five patients were recruited. Subjects were enrolled over a 36-month period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Results showed that demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, the only difference being type of health insurance among enrolled patients. Sites were divided into three groups by the number of enrolled subjects. Comparing these three groups, the Columbia site had fewer ‘definite ALS’ diagnoses. This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and has been accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized.

Key words::

• ALS
• oxidative stress
• disease progression
• survival
• epidemiology

Acknowledgement

We are deeply grateful to the patients and their families who enthusiastically participated in this labor-intensive study. We would like to express our thanks to Annette Kirshner at NIEHS for her kind advice and strong support. NIH funded the entire study and MDA funded an earlier study, which was incorporated into the ALS COSMOS study. MDA Wings, Adams Foundation, and Ride for Life supported part of the study as well. Georgia Christodouloum reviewed the manuscript.

ALS COSMOS Study Group: Site Investigators

Columbia University Coordinating Center, New York, NY: Hiroshi Mitsumoto, Jonathan Hupf, Jess Singleton, Christa Campanella, David Merle, Tejal Shah, Meredith Pasmantier Kim, Yei-Won Lee, Georgia Christodoulou, Kate Dalton, Jessica Kidd, Erin Gilbert, Mary Kilty; Texas Neurology, P.A., Dallas, TX: Daragh Heitzman, Wendy Rodriguez, Shari Hand, Michelle Washington, Brent Spears, Brandie Burson; Duke University, Durham, NC: Richard S. Bedlack, Karen Grace, Candace Boyette; California Pacific Medical Center, San Francisco, CA: Jonathan S. Katz, Robert G. Miller, Dallas Forshew, Joni Beemsterboer, Will Harris, Shelley McCoy, Thaïs Zayas-Bazan, Chow Saephanh; University of Kansas, Kansas City, KS: Richard J. Barohn, April L. McVey, Mazen M. Dimachkie, Mamatha Pasnoor, Yunxia Wang, Maureen Walsh, Laura Herbelin, JoAnn Miller, Kristy Anderson; Mayo Clinic, Rochester, MN: Eric J. Sorenson, Sherry Klingerman, Delana Weis; University of California, Davis, Sacramento, CA: Björn Oskarsson, Nanette Joyce, Steffany Lim, Michelle Cregan; University of Kentucky, Lexington, KY: Edward J. Kasarskis, Kathie Vanderpool, Deborah Taylor, Samantha Thomas, Jason King, Robert Wells; University of California, San Francisco, San Francisco, CA: Catherine Lomen-Hoerth, Jennifer Murphy (UCSF, Cognitive Psychology), Y-Nhy Duong, Dennis Robins, Claudia Villerme; University of Colorado, Aurora, CO: Yvonne D. Rollins, Steven P. Ringel, Dianna Quan, Elizabeth Whitethorn; University of California, Irvine, Orange, CA: Tahseen Mozaffar, Annabel K. Wang, Veronica Martin, Brian Minton, Patricia Tully, Denise Davis; University of Nebraska Medical Center, Omaha, NE: J. Americo M. Fernandes Filho, Pariwat Thaisetthawatkul, Cindy Cowardin, Russell Herstein; University of Iowa, Iowa City, IA: Andrea J. Swenson, Decontee Jimmeh-Fletcher, Heena Olalde, Jeri Sieren; University of Texas - Southwestern, Dallas, TX: Sharon P. Nations, Jeffrey Elliott, Jaya Trivedi, Nina Gorham; SUNY - Upstate Medical University, Syracuse, NY: Jeremy M. Shefner, Mary Lou Watson, Jennifer Moore, Katie Markis, Megan Grosso; Hospital for Special Care, New Britain, CT: Jinsy A. Andrews, Agnes Koczon-Jaremko, Janet Bowen.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.