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

• ClinicalTrials.gov Identifier: NCT00104585
• Recruitment Status: Unknown
• First Posted: March 2, 2005
• Last Update Posted: January 19, 2012
• Sponsor: Columbia University
• 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

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

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