Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367900
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2006-08-22
Brief Title:
Parkinsons Genes and Environment Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Parkinsons Genes and Environment PAGE Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the roles of diet lifestyle genes and their possible interactions in the cause of Parkinsons 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 567169 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 Parkinsons disease will include approximately 9000 participants from the NIH-AARP study - 3000 of whom reported being diagnosed with Parkinsons disease on the most recent survey and 6000 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 Parkinsons disease are asked permission to review medical information regarding their diagnosis
The current NIH-AARP substudy on Parkinsons disease will include approximately 9000 participants from the NIH-AARP study - 3000 of whom reported being diagnosed with Parkinsons disease on the most recent survey and 6000 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 Parkinsons disease are asked permission to review medical information regarding their diagnosis
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 1208 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-E-N093 | None | None | None |