Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042107
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2002-07-24
Brief Title:
Molecular Epidemiology of Parkinsons Disease
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-07
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:
The aim of this research is to discover genes which modify risk for Parkinsons disease The study includes 800 patients with Parkinsons disease and their estimated 1222 available siblings Common variations of at least 9 genes will be studied including genes associated with personality substance use and anxiety and depression
Detailed Description:
Parkinsons disease PD is a common and disabling condition in the expanding elderly population of the US and worldwide Its etiology remains unknown and both genetic and environmental factors have been suspected The long-term goal of the proposed studies is to clarify the etiology of PD and to identify means to prevent it Specifically we will study the association of PD with susceptibility genes previously found associated with novelty seeking behavior substance use tobacco alcohol and caffeine and anxiety and depressive disorders The hypotheses tested derive directly from our current work and preliminary findings We will employ the case-unaffected sibling control study design and analyses will use a generalization of the sibling transmission dysequilibrium test or S-TDT In total nine candidate susceptibility genes will be considered of which only five have undergone limited study for PD The candidate susceptibility genes include three detoxification genes three dopaminergic genes and three serotonergic genes We will include 800 cases of PD referred to the Mayo Clinic from a 120-mile radius or from a 5-state region during approximately a 10-year period We will also include their eligible siblings age 40 years or above projecting that blood DNA samples will be available for 563 affected probands or siblings and 1180 unaffected siblings stratified in 521 informative sibships Sibships with multiple affected or unaffected siblings will be included PD cases will undergo a clinical assessment and blood sampling and provide family information through a face-to-face interview followed by a written mail-in form All living siblings ages 40 and above will be screened for PD using a validated telephone instrument Subjects screening negative for PD will provide DNA with mail-in blood sampling kits only Persons screening positive will be clinically assessed at the Mayo Clinic or at home and blood DNA samples will be directly obtained Genotyping will be performed using polymerase chain reaction methods and will be blinded to affected or unaffected status The study will avoid population stratification bias by using sibling controls The candidate susceptibility genes selected for primary analyses relate to personality traits substance use and psychiatric diseases that we have found associated with PD The selection of these genes represents a major paradigm shift We will also establish a large DNA bank for rapid and efficient testing of new genetic hypothesis for PD This application is submitted in response to RFA ES-00-002 The Role of the Environment in Parkinsons Disease We specifically address the RFAs objectives of evaluating endogenous including biomarkers and exogenous including dietary and lifestyle susceptibility factors for PD using molecular epidemiology tools
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