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Parkinson's Genes and Environment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367900
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Brief Summary:

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 or disease
Parkinson's Disease

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.


  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.

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Study Type : Observational
Actual Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Parkinson's, Genes and Environment (PAGE) Study
Study Start Date : February 8, 2006

Resource links provided by the National Library of Medicine

NIH-AARP Diet and Health Study sub study: PAGE
Diet and Health Study members who self-reported a Parkinson's disease (PD) diagnosis on a follow-up questionnaire, and randomly selected controls, will participate in the PAGE sub study.

Primary Outcome Measures :
  1. Examine factors that increase or decrease risk of PD [ Time Frame: duration of study ]
    Parkinson s disease diagnosis - we validated Parkinson s diagnosis by collecting and reviewing diagnostic information from study participants and their treating physicians. In addition, we collected saliva sample for genetic assays and additional exposure data for analyses.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 3,000 NIH-AARP Diet and Health Study participants who reported a Parkinson's disease (PD) diagnosis on the most recent survey (conducted 2004-2006)and 6,000 control subjects from the cohort who did not report a PD diagnosis.@@@

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00367900

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United States, North Carolina
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Gitanjali Taneja, Ph.D. National Institute of Environmental Health Sciences (NIEHS)

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Responsible Party: National Institute of Environmental Health Sciences (NIEHS) Identifier: NCT00367900    
Other Study ID Numbers: 999906093
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: May 3, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Neurodegenerative Diseases
Elderly Population
Public Health
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases