Parkinson's Genes and Environment Study

The Parkinson's, Genes and Environment (PAGE) Study

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.

Study Overview

• Status: Completed
• Conditions: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 3100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • NIEHS, Research Triangle Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.@@@

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine factors that increase or decrease risk of PD	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.	duration of study

Collaborators and Investigators

• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Gitanjali Taneja, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

General Publications

• Chen H, Zhang SM, Hernan MA, Willett WC, Ascherio A. Diet and Parkinson's disease: a potential role of dairy products in men. Ann Neurol. 2002 Dec;52(6):793-801. doi: 10.1002/ana.10381.
• Ascherio A, Zhang SM, Hernan MA, Kawachi I, Colditz GA, Speizer FE, Willett WC. Prospective study of caffeine consumption and risk of Parkinson's disease in men and women. Ann Neurol. 2001 Jul;50(1):56-63. doi: 10.1002/ana.1052.
• Chen H, Zhang SM, Hernan MA, Schwarzschild MA, Willett WC, Colditz GA, Speizer FE, Ascherio A. Nonsteroidal anti-inflammatory drugs and the risk of Parkinson disease. Arch Neurol. 2003 Aug;60(8):1059-64. doi: 10.1001/archneur.60.8.1059.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2006
• Primary Completion (Actual): November 30, 2009
• Study Completion (Actual): June 4, 2014

Study Registration Dates

• First Submitted: August 22, 2006
• First Submitted That Met QC Criteria: August 22, 2006
• First Posted (Estimate): August 23, 2006

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Diet; Parkinson Disease; Environment; Neurodegenerative Diseases; Public Health; Lifestyle; Elderly Population
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 999906093; 06-E-N093