NCT00377351

Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a rare but rapidly progressive neurological disease that often results in death within a few years after the diagnosis. The incidence of ALS in the US is approximately 2.0/100,000/year and is age dependent. Very few epidemiological studies have investigated the causes of ALS. Last year, Dr. Alberto Ascherio at Harvard School of Public Health successfully obtained a RO1 grant to investigate the risk of ALS by documenting ALS cases in five well-established large prospective cohorts: The Nurses' Health Study (NHS), the Health Professionals Follow-up Study (HPFS), the Cancer Prevention Study II Nutrition Cohort (CPS IIN), the Multiethnic Cohort (MEC), and the NIH-American Association of Retired Persons Diet and Health Study (AARP-DH). The primary aims of this grant are to prospectively clarify the associations between diet and smoking and risk of ALS in this to date the largest epidemiological study on ALS. Incident ALS cases will be documented via biennial questionnaires in the first three cohorts. While mortality data will be obtained in the MEC and AARP-DH cohorts by searching the National Death Index (NDI) Plus, it is also desirable to identify surviving incident cases in these two cohorts. The objective of this specific proposal is to ascertain the self-reported incident ALS cases from the AARP-DH study and obtain consent for medical release following the procedures set up for Parkinson's disease (PD) cases in the currently approved Parkinson's Genes and Environment (PAGE) Study IRB approval #06-E-N093. The confirmed ALS cases may be analyzed as part of the RO1 project. We expect to identify 300 self-reported ALS cases from the AARP cohort. Detailed analytic plans will be coordinated with Dr. Ascherio.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2010

Completed
Last Updated

July 2, 2017

Status Verified

August 3, 2010

First QC Date

September 15, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Public HealthElderly PopulationNeurodegenerative DiseasesExposureLifestyle

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This study will be conducted within the infrastructure of the NIH-AARP Diet and Health Study; every participant in the AARP cohort self-reporting an ALS diagnosis will be eligible for the current investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (3)

  • McGuire V, Longstreth WT Jr, Koepsell TD, van Belle G. Incidence of amyotrophic lateral sclerosis in three counties in western Washington state. Neurology. 1996 Aug;47(2):571-3. doi: 10.1212/wnl.47.2.571.

    PMID: 8757041BACKGROUND
  • Kamel F, Umbach DM, Lehman TA, Park LP, Munsat TL, Shefner JM, Sandler DP, Hu H, Taylor JA. Amyotrophic lateral sclerosis, lead, and genetic susceptibility: polymorphisms in the delta-aminolevulinic acid dehydratase and vitamin D receptor genes. Environ Health Perspect. 2003 Aug;111(10):1335-9. doi: 10.1289/ehp.6109.

    PMID: 12896855BACKGROUND
  • Kamel F, Umbach DM, Munsat TL, Shefner JM, Hu H, Sandler DP. Lead exposure and amyotrophic lateral sclerosis. Epidemiology. 2002 May;13(3):311-9. doi: 10.1097/00001648-200205000-00012.

    PMID: 11964933BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

September 11, 2006

Study Completion

August 3, 2010

Last Updated

July 2, 2017

Record last verified: 2010-08-03

Locations