Consortium On Risk for Early-onset Parkinson's Disease (CORE PD)
Tracking Information | |||||
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First Received Date ICMJE | March 1, 2005 | ||||
Last Updated Date | January 18, 2012 | ||||
Start Date ICMJE | July 2004 | ||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
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Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00104585 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Consortium On Risk for Early-onset Parkinson's Disease (CORE PD) | ||||
Official Title ICMJE | 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). |
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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. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Family-Based Time Perspective: Cross-Sectional |
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Biospecimen | Retention: Samples With DNA Description: whole blood |
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Sampling Method | Non-Probability Sample | ||||
Study Population | Young onset PD patients |
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Condition ICMJE | Parkinson's Disease | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | 1
People with young onset Parkinson's disease and their family members |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 800 | ||||
Completion Date | |||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00104585 | ||||
Other Study ID Numbers ICMJE | AAAA5609, R01NS036630 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Columbia University | ||||
Study Sponsor ICMJE | Columbia University | ||||
Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Investigators ICMJE |
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Information Provided By | Columbia University | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |