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Confirmation of Self-Reported Incident ALS Cases in the AARP-Diet and Health (AARP-DH) Cohort
NCT00377351 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Study Locations (1)
North Carolina
- NIEHS, Research Triangle Park — Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-09-11 |
| Est. Completion | 2010-08-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00377351
The ClinicalTrials.gov registry entry for NCT00377351 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 75 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00377351 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00377351?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 75 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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