Parkinson's Genes and Environment Study

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00367900
First received: August 22, 2006
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

This study will examine the roles of diet, lifestyle, genes, and their possible interactions in the cause of Parkinson's disease, using information from the NIH-AARP Diet and Health Study. The NIH-AARP study was established in 1995 to examine the roles of diet and lifestyle in cancer. It included 567,169 AARP members 50 or older from California, Florida, North Carolina, Pennsylvania, New Jersey, Louisiana, and the Atlanta and Detroit metropolitan areas. In 1995, participants completed a comprehensive questionnaire on diet and a survey on demographics, medications, as well as a follow-up survey in 1996 with more detailed questions on lifestyle and medications, as well as cooking methods and early life dietary habits. A third followup survey is currently underway.

The current NIH-AARP substudy on Parkinson's disease will include approximately 9,000 participants from the NIH-AARP study - 3,000 of whom reported being diagnosed with Parkinson's disease on the most recent survey, and 6,000 control subjects. These study participants provide two saliva samples for genetic analysis and may be asked to complete a telephone interview. In addition, those with Parkinson's disease are asked permission to review medical information regarding their diagnosis.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Parkinson's, Genes and Environment (PAGE) Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 3100
Study Start Date: February 2006
Detailed Description:

Parkinson s disease (PD) is the second most prevalent neurodegenerative disease, affecting more than 1 million elderly Americans. The causes of PD are largely unknown, but may include both genetic and environmental factors. We thus propose a large study to investigate the roles of diet, lifestyle, genes and their potential interactions in PD etiology, using the NIH-AARP Diet and Health Study. The AARP cohort was established by investigators at NCI and recruited over half a million participants in 1995 and had prospectively collected detailed information on diet and lifestyle. At baseline, participants were 50 years or older and included 40% women. After more than 8 years of follow-up, we expect to confirm 1,208 incident PD cases with their neurologists. We will comprehensively examine the associations between diet and lifestyle and risk of PD, focusing on dietary antioxidants, fat, caffeine, dairy products, estrogen use, obesity, physical activity, and non steroidal anti-inflammatory drugs (NSAIDs). Further, we will collect saliva samples from PD patients and selected controls without PD for genetic analysis. These results will be used to explore the PD associations with several common genetic polymorphisms and, for the first time, their interactions with several promising diet or lifestyle exposures. Many of the specific aims are novel and important but have been rarely examined in previous investigations. The findings will improve our understanding of the complex relationships among diet, lifestyle, gene-environment interaction, and PD etiology and may potentially contribute to successful PD prevention strategies.

Study Aims:

  1. Examine dietary factors that may increase or decrease PD risk.
  2. Examine lifestyle factors that may increase or decrease PD risk.
  3. Examine genetic polymorphisms in relation to PD risk and their interactions with diet

and lifestyle on PD risk.

Study Population: The NIH-AARP Diet and Health Study cohort.

Design:

  1. Longitudinal study for the first two study aims
  2. Nested case-control study for the third study aim.

Outcome Parameters: Physician confirmed PD diagnoses.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

This study will be conducted within the infrastructure of the NIH-AARP Diet and Health Study; every participant in the AARP cohort will be eligible for the current investigation. Individuals with PD at baseline (prevalent cases) or with missing information on exposure variables are still eligible for the study, but may be excluded from specific analysis.

The proposed study does not require new recruitment.

EXCLUSION CRITERIA:

No children are included.

The analytic sample includes all participants who respond to the follow-up questionnaires and have non-missing values on the baseline surveys. Participants who reported PD before exposure assessment may be excluded from the analyses.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367900

Locations
United States, North Carolina
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
Principal Investigator: Honglei Chen, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00367900     History of Changes
Other Study ID Numbers: 999906093, 06-E-N093
Study First Received: August 22, 2006
Last Updated: June 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diet
Lifestyle
Neurodegenerative Diseases
Elderly Population
Public Health
Parkinson Disease
Environment

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 23, 2014