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Consortium On Risk for Early-onset Parkinson's Disease (CORE PD)

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ClinicalTrials.gov Identifier: NCT00104585
Recruitment Status : Unknown
Verified January 2012 by Columbia University.
Recruitment status was:  Recruiting
First Posted : March 2, 2005
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date March 1, 2005
First Posted Date March 2, 2005
Last Update Posted Date January 19, 2012
Study Start Date July 2004
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00104585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Consortium On Risk for Early-onset Parkinson's Disease (CORE PD)
Official Title Genetic Epidemiology of Parkinson's Disease
Brief Summary The purpose of this study is to investigate genetic and environmental risk factors that increase susceptibility to the development of early-onset Parkinson's disease (developed at or before age 50).
Detailed Description

Parkinson's disease (PD) is a common, neurodegenerative condition. Although mostly a late-onset disorder, 10 percent of people with PD are reported to develop symptoms before the age of 50. To date, six genes have been found to be associated with PD, however the majority have been found in rare PD 'families'. Some studies have also identified a number of environmental risk factors, such as pesticide use, that appear to increase the risk of PD.

In a previous study, Dr. Karen Marder and her research team found that close family members of people with both early- and late-onset PD have a three-fold increased risk of PD compared to close family members of people without PD.

The purpose of the Consortium On Risk for Early-onset Parkinson's Disease (CORE PD) study is to identify the genetic factors that contribute to the development of early-onset Parkinson's disease, and to understand how these genetic factors interact with other genes and the environment to cause PD.

Participation in the study involves a blood draw (to look for genetic factors associated with PD), questionnaires collecting information on family and medical history, and a neurological examination. In addition participants may be contacted in the future and asked to participate in a more detailed interview. At that time, study investigators will also ask participants for permission to contact family members to invite them to participate in the study.

This research study requires participants to sign a consent form, which states that the research is voluntary and confidential. In addition, since this is a research study, genetic results are not released to participants or their family members now or in the future.

Scientists hope this multi-center study will increase the current knowledge of PD and that the identification of factors that cause PD will lead to better diagnosis and treatment.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Young onset PD patients
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts 1
People with young onset Parkinson's disease and their family members
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June¬†23,¬†2005)
800
Original Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any person with Parkinson's disease in the United States whose symptoms began at age 50 or younger and was diagnosed by a neurologist.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00104585
Other Study ID Numbers AAAA5609
R01NS036630 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Columbia University
Study Sponsor Columbia University
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Karen Marder, M.D., M.PH. Columbia University
PRS Account Columbia University
Verification Date January 2012