- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011154
Exogenous Toxicants and Genetic Susceptibility in ALS
March 22, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a fatal neurodegenerative disease that poses a significant burden for affected individuals and their family members.
The principal objective of this epidemiologic study is to identify environmental and genetic risk factors for ALS.
Of primary interest is whether environmental chemicals such as heavy metals, pesticides and organic solvents contribute to the cause of ALS.
We also aim to identify genetic factors that contribute to the risk of ALS because individuals with certain genetic traits may be unable to protect against the toxic effects of chemical exposure.
Other factors that may protect against the development of ALS, such as dietary antioxidants, are also under investigation.
If modifiable factors affecting the risk for ALS could be identified, interventions to delay or even prevent the development of ALS could be developed.
Study Overview
Status
Completed
Conditions
Detailed Description
The principal objective of this study is to identify environmental and/or genetic risk factors for amyotrophic lateral sclerosis (ALS).
We are addressing this objective by conducting a case-control study of ALS in the Northern California Kaiser Permanente Medical Care Program (KPMCP).
Over a four-year period, approximately 175 persons newly diagnosed with ALS will be identified and recruited through physician referrals and computerized mechanisms available within the Kaiser system.
The patients with ALS will be compared to a sample of 350 age- and gender-matched persons without ALS from the same membership.
Specific study aims are as follows: (1) to investigate the association of ALS with exposure to neurotoxicants including lead, other heavy metals, solvents and pesticides; (2) to determine whether inadequate oxidative defenses for protecting against free-radicals enhance the toxicity of exogenous exposures; (3) to examine the evidence for familial aggregation of neurodegenerative diseases among first-degree relatives of patients with ALS; and (4) to estimate the incidence of ALS in diverse racial and ethnic groups.
Study Type
Observational
Enrollment
525
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Individuals with ALS within the Kaiser Permanente population of Northern California, ages 18 years and older, with first diagnosis of ALS in the years 1996-2000.
Controls are individuals who are age- and sex-matched to the patients with ALS, also from the Kaiser Permanente population.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1996
Study Completion
August 1, 2002
Study Registration Dates
First Submitted
February 12, 2001
First Submitted That Met QC Criteria
February 13, 2001
First Posted (Estimate)
February 14, 2001
Study Record Updates
Last Update Posted (Estimate)
March 23, 2006
Last Update Submitted That Met QC Criteria
March 22, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8150-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyotrophic Lateral Sclerosis
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Washington University School of MedicineMassachusetts General HospitalSuspendedAmyotrophic Lateral Sclerosis, Familial | Amyotrophic Lateral Sclerosis, SporadicUnited States
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University of Sao Paulo General HospitalPontifícia Universidade Católica do ParanáUnknownAMYOTROPHIC LATERAL SCLEROSISBrazil
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Neuromed IRCCSRecruitingAmyotrophic Lateral Sclerosis (ALS)Italy
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Humanitas Mirasole SpAKU Leuven; UMC Utrecht; University of Sheffield; Istituto Superiore di Sanità; University... and other collaboratorsActive, not recruitingAmyotrophic Lateral Sclerosis (ALS)United Kingdom, Germany, France, Netherlands, Belgium, Ireland, Italy
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The Methodist Hospital Research InstituteMassachusetts General Hospital; The Center for Clinical and Translational Sciences... and other collaboratorsActive, not recruiting
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CytokineticsCompletedAmyotrophic Lateral Sclerosis (ALS)United States, Netherlands, Canada, Belgium, United Kingdom, France, Germany, Ireland, Italy, Portugal, Spain
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Columbia UniversityALS AssociationTerminatedAmyotrophic Lateral Sclerosis (ALS)United States
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El Instituto Nacional de Neurologia y Neurocirugia...CompletedAmyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis, SporadicMexico
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University Hospital, GenevaCompletedAmyotrophic Lateral Sclerosis 11Switzerland
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Fondazione Don Carlo Gnocchi OnlusFondazione Salvatore MaugeriCompleted