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NCT00377351 · ClinicalTrials.gov registry record

Confirmation of Self-Reported Incident ALS Cases in the AARP-Diet and Health (AARP-DH) Cohort

A clinical trial of Amyotrophic Lateral Sclerosis, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Completed
Registry status
21
Enrollment target
1
Study location

NCT00377351 is a study of Amyotrophic Lateral Sclerosis that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 21 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00377351, a study of Amyotrophic Lateral Sclerosis, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).

COMPLETED
Registry status
21 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

North Carolina

  • NIEHS, Research Triangle Park - Research Triangle Park

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2006-09-11
Est. Completion 2010-08-03

What the Registry Record Tells You About NCT00377351

The ClinicalTrials.gov registry entry for NCT00377351 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 0 interventions.

NCT00377351 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00377351 about?

NCT00377351 is a clinical study titled "Confirmation of Self-Reported Incident ALS Cases in the AARP-Diet and Health (AARP-DH) Cohort". 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...

What is the current status of trial NCT00377351?

This trial is currently completed. The enrollment target is 21 participants. The study started on 2006-09-11. Estimated completion is 2010-08-03.

What conditions does trial NCT00377351 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.

Who is sponsoring clinical trial NCT00377351?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00377351 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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