NCT00377351

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

Completed Last updated 2 July 2017

What this trial tests

trial in Amyotrophic Lateral Sclerosis in 21 participants. Completed in 3 August 2010.

Timeline

11 September 2006

3 August 2010

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	21
Start date	11 September 2006
Estimated completion	3 August 2010
Sites	1 location across United States

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 50 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Management and Prevention of Neurodegenerative Disorders: Can Antioxidant-Rich Dietary Interventions Help?
   Nagpal D, Nema S, Nagpal S, Pandey MM, et al · · 2025 · cited 2× · PMID 41008984 · DOI 10.3390/antiox14091078