- 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.
- 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.
If you've recently received an ALS diagnosis and want to find out more about the study, contact one of the following study sites.
University of California, Irvine
Veronica Martin, coordinator
Phone: (714) 456-2332
University of California-Davis
Roxana Hupcey, coordinator
Phone: (916) 734-6244
California Pacific Medical Center
Dallas Forshew, coordinator
Phone: (415) 600-3938
Will Harris, coordinator
Phone: (415) 600-3967
University of California-San Francisco
Catherine Lomen-Hoerth, M.D., principal investigator
Jennifer Murphy, Ph.D., principal investigator
Phone: (415) 514-0490
University of Colorado
Elizabeth Whitethorn, coordinator
Phone: (303) 724-2186
Kansas University Medical Center
Laura Herbelin, coordinator
Phone: (913) 588-5095
Maureen Walsh, coordinator
Phone: (913) 588-0645
University of Kentucky
Jason King, coordinator
Phone: (859) 218-5062
Sherry Klingerman, coordinator
Phone: (507) 284-0451
Columbia University Medical Center
New York City
Kate Dalton, coordinator
Phone: (212) 305-2027
Upstate Medical Center
Katie Markis, coordinator
Phone: (315) 464-4998
Mary Lou Watson, coordinator
Duke University Medical Center
Karen Grace, coordinator
Phone: (919) 668-2844
Shari Hand, coordinator
Brent Spears, coordinator
Phone: (214) 279-0326