Participants Sought for Three ALS Trials

Research scientists are seeking individuals interested in participating in any of the following three trials in ALS.

High-fat, high-calorie diets

Enrollment is open in an MDA-supported study comparing three tube-feeding formulas – one high in calories; one high in fat calories; and one standard formula – in people with ALS.

The trial has been designed to test the hypothesis, suggested by observational studies and studies in mice, that a high-fat and/or high-calorie diet can significantly increase survival in ALS.

"Patients have long been told to increase the amount of calories they take, because we know that weight loss is bad for ALS. But nobody knows exactly how much to increase their calories or what kind of diet they should be eating," said neurologist and study principal investigator Mary-Anne Wills at Massachusetts General Hospital in Boston. "This study will compare different types of diets to see which are best tolerated and least likely to cause side effects. We hope that if one of the high-calorie diets work, we will be able to see an improvement in lifespan as well."

Participants must be tolerating tube feedings and must meet other study criteria.

The study is being conducted at the five centers that make up the MDA/ALS Clinical Research Network: California Pacific Medical Center, San Francisco; Columbia University, New York; Emory University, Atlanta; Massachusetts General, Boston; and Methodist Hospital, Houston. Recruitment also is open at the University of California, Irvine, and additional sites are expected to be added soon, including the University of Vermont in Burlington, Drexel University in Philadelphia, and the Mayo Clinic in Jacksonville, Fla.

For more information, contact Katy Shaver at Massachusetts General Hospital at (617) 643-7434 or kshaver@partners.org.

Biomarkers

Investigators at approximately 30 institutions are looking for individuals with and without ALS to participate in a study designed to identify biological indicators ("biomarkers") in the blood and spinal fluid that are unique to ALS. Biomarkers are valuable tools that can help improve ALS diagnosis, track disease progression, and predict and monitor an individual's response to treatments.

A total of 650 blood and 300 spinal fluid samples will be collected from healthy people, people with ALS, and people with diseases mimicking ALS, at an initial visit and, for those with ALS, after six, 12 and 18 months.

The study's principal investigator is Merit Cudkowicz, who directs the MDA/ALS Center at Massachusetts General Hospital in Boston.

Contact Daniela Grasso at (617) 726-0842 or dgrasso@partners.org. For details and a complete list of study sites, see the Northeast ALS Consortium site at www.nealsconsortium.org.

Ceftriaxone

A 600-person trial of intravenous ceftriaxone, an antibiotic, remains open at several North American sites. Laboratory studies suggest the drug protects motor neurons from injury.

Participants' ALS symptoms must have existed for no more than three years. Inclusion criteria include a vital capacity (breathing measurement) of at least 60 percent of normal and a caregiver to help administer study medication.

U.S. study sites are located in Arizona; California; Colorado; Connecticut; Washington, D.C.; Florida; Georgia; Illinois; Indiana; Kansas; Kentucky; Massachusetts; Michigan; Minnesota; Missouri; Nebraska; New Jersey; New York; North Carolina; Ohio; Oregon; Pennsylvania; Tennessee; Texas; Utah; Vermont; and Virginia. Canadian study sites are in Ontario and Quebec.

Contact Sarah Titus, assistant project manager, at (617) 726-1398, or stitus@partners.org. For all site contacts, see www.alsconsortium.org.

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