Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis

Status Completed

Clinical Trial Summary

This study is a follow-up to an earlier study that examined the relationship of This study will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The cause of this degenerative disease of the brain and spinal cord is not well understood. Some studies suggest that exposure to environmental neurotoxins may increase its risk. This follow-up study will examine the relationship of neurotoxin exposure to the interval between the diagnosis of ALS and death. It will also examine the possible roles of genetics, lifestyle and dietary factors in the disease. Information on ALS patients previously enrolled in the study will be used to examine this relationship. No new individuals will be enrolled in the study.

Clinical Trial Description

Objective: The objective of this proposal is linkage with the National Death Index (NDI) for cases from a study that was conducted in the early 1990's. The purpose of the initial study was to examine the role that lead and other exposures, including mercury and solvents, play in the etiology of amyotrophic lateral sclerosis (ALS).

Study population: The study involved 110 ALS cases and 256 population based controls, recruited in New England between 1993 and 1996. Data collection involved an interview, blood collection, and measurement of bone lead using x-ray fluorescence.

Design and outcome parameters: The results of this study suggested that lead exposure was a risk factor for ALS. Compared to controls, cases were more likely to have occupational lead exposure, and both blood and bone lead levels were higher in cases. We are presently analyzing data on other neurotoxic exposures including mercury, solvents, and pesticides. In order to investigate prognosis, we would like to determine the date of death by searching the National Death Index. This information will enable us to evaluate the relationship of neurotoxic exposures to ALS prognosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00339976
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	N/A
Start date	August 6, 2002
Completion date	April 21, 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.