Study to Probe Oxidative Stress in People With ALS

by Margaret Wahl on Mon, 2010-07-26 16:56

Participants are being sought for a 12-center study that will follow people with ALS over time to examine relationships between the disease and oxidative stress

Article Highlights:
  • Participants are now being recruited for a new large-scale study that will probe the relationship between oxidative stress, a cell-damaging phenomenon, and the ALS disease process, with an eye to treatment development.
  • The study has support from MDA and the National Institutes of Health (NIH).
  • Oxidative stress results from an excess of toxic byproducts of cellular energy production and is believed to be a contributing factor in ALS.
  • More than 400 people with a recent ALS diagnosis will be followed through time. The study is recruiting now.

More than 400 people who recently received an ALS diagnosis are being sought for a large study of a cell-damaging phenomenon called "oxidative stress," common in ALS and other degenerative diseases.

Oxidative stress is a type of damage that results from high levels of toxic byproducts of energy production inside cells. These toxic chemicals — known as free radicals — normally are present, but when they're produced in excess or when cells become unable to detoxify them, they become dangerous.

About the new study

The investigators, supported by MDA and the National Institutes of Health (NIH), are seeking to understand the relationship of oxidative stress to the ALS disease process and to see whether there are factors other than the disease itself (such as environmental exposures) that may influence oxidative stress.

The study started at Columbia University in New York and has now expanded to include 12 sites in California, Colorado, Kansas, Kentucky, Minnesota, New York, North Carolina and Texas.  

Investigators say the project is the first in-depth, multicenter attempt to examine oxidative stress in ALS "prospectively," meaning starting at a time point and following patients through time. They expect the study to increase understanding of disease mechanisms and hope it will lead to new treatments and perhaps to preventive approaches to the disease.

Specifically, the researchers aim to

  • determine whether increased oxidative stress is associated with the progression of ALS;
  • examine the associations between oxidative stress and survival in ALS;
  • determine whether a variety of environmental, lifestyle and psychological factors measured at baseline (the start of the study) are associated with increased levels of oxidative stress markers measured at baseline;
  • evaluate associations between lipid profiles (such as serum cholesterol and triglyceride measurements) and ALS progression; and
  • examine possible associations between oxidative stress and distinct subtypes of ALS, such as bulbar- or spinal-onset ALS, and ALS with or without dementia (severe cognitive impairment).

Study participants will be asked to answer questions, in writing or over the phone, about employment history, lifestyle, psychological issues and diet.

They will be followed every three or six months for two years. The amount of testing varies by visit but may include collection of questionnaires, pulmonary function tests, neurological and physical exams, cognitive tests, blood or urine tests, or a skin biopsy. 

Participants must

  • have a diagnosis of ALS or possible ALS;
  • be at least 20 years old;
  • have experienced symptom onset within the last 18 months;
  • be fluent in English;
  • pass the Capacity Assessment Record evaluation confirming that they understand the information in the consent and HIPAA forms and are able to sign them;
  • reside within commutable distance of a study site (see below) and be willing to visit it as required; and
  • have a reliable caregiver (relative, spouse, domestic partner or other unpaid household member) who is willing to assist in communicating information in interviews and questionnaires.

Participants must not

  • have a family history of ALS;
  • be participating in any pharmaceutical clinical trials before baseline specimens are collected;
  • have any active major neurological diseases other than ALS;
  • have any history of other major neurological diseases; or
  • have had any major, unstable medical diseases (such as cancer or kidney disease) that required treatment (such as dialysis) within the past six months.

Contact Info

If you've recently received an ALS diagnosis and want to find out more about the study, contact one of the following study sites.

California

University of California, Irvine

Veronica Martin, coordinator

Phone: (714) 456-2332

E-mail: vero@uci.edu

 

University of California-Davis

Roxana Hupcey, coordinator

Phone: (916) 734-6244

E-mail: roxana.hupcey@ucdmc.ucdavis.edu

 

California Pacific Medical Center

San Francisco

Dallas Forshew, coordinator

Phone: (415) 600-3938

E-mail: ForsheD@cpmcri.org

Will Harris, coordinator

Phone: (415) 600-3967

E-mail: HarrisCW@cpmcri.org

 

University of California-San Francisco

Catherine Lomen-Hoerth, M.D., principal investigator

E-mail: Catherine.Lomen-Hoerth@ucsf.edu

Jennifer Murphy, Ph.D., principal investigator

Phone: (415) 514-0490

E-mail: jennifer.murphy@ucsf.edu

 

Colorado 

University of Colorado

Denver

Elizabeth Whitethorn, coordinator

Phone: (303) 724-2186

E-mail: Elizabeth.Whitethorn@ucdenver.edu

 

Kansas 

Kansas University Medical Center

Kansas City

Laura Herbelin, coordinator

Phone: (913) 588-5095

E-mail: LHERBELIN@kumc.edu

Maureen Walsh, coordinator

Phone: (913) 588-0645

E-mail: mwalsh2@kumc.edu

 

Kentucky 

University of Kentucky

Lexington

Jason King, coordinator

Phone: (859) 218-5062

E-mail: jtking0@uky.edu

 

Minnesota 

Mayo Clinic

Rochester

Sherry Klingerman, coordinator

Phone: (507) 284-0451

E-mail: klingerman.sherry@mayo.edu

 

New York 

Columbia University Medical Center

New York City

Kate Dalton, coordinator

Phone: (212) 305-2027

E-mail: keb2114@columbia.edu

 

Upstate Medical Center

Syracuse

Katie Markis, coordinator

Phone: (315) 464-4998

E-mail: markisk@upstate.edu

Mary Lou Watson, coordinator

E-mail: watsonma@upstate.edu

 

North Carolina 

Duke University Medical Center

Durham

Karen Grace, coordinator

Phone: (919) 668-2844

E-mail: karen.grace@duke.edu

 

Texas 

Texas Neurology

Dallas

Shari Hand, coordinator

Brent Spears, coordinator

Phone: (214) 279-0326

E-mail: shand@rhizomeresearch.com

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