Viewing Study NCT00011154



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Study NCT ID: NCT00011154
Status: COMPLETED
Last Update Posted: 2006-03-23
First Post: 2001-02-12

Brief Title: Exogenous Toxicants and Genetic Susceptibility in ALS
Sponsor: National Institute of Environmental Health Sciences NIEHS
Organization: National Institute of Environmental Health Sciences NIEHS

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2006-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Amyotrophic lateral sclerosis ALS also known as Lou Gehrigs 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
Detailed Description: The principal objective of this study is to identify environmental andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None