Parkinson's DiseaseNCT00104585
Consortium On Risk for Early-onset Parkinson's Disease (CORE PD)
An observational study of Parkinson's Disease, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young onset Parkinson's disease patients
Who may be able to join
- Any person with Parkinson's disease in the United States
- Symptoms occurred before the age of 50
- Diagnosed by a neurologist.
Who cannot join
- Children who are <18 years of age
- Any probands who are cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Epidemiology of Parkinson's Disease
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, PD, gene, environment, early-onset Parkinson's disease
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young onset Parkinson's disease | People with young onset Parkinson's disease and their family members |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startJul 2004
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Marder, M.D., M.PH., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104585
- Sponsor's protocol ID
- AAAA5609
- Other IDs
- R01NS036630
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2005
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00104585
- Acronym / sponsor ID
- AAAA5609
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, PD, gene, environment, early-onset Parkinson's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2004
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young onset Parkinson's disease | – | –People with young onset Parkinson's disease and their family members |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young onset Parkinson's disease patients
Key inclusion criteria (3 listed)
- Any person with Parkinson's disease in the United States
- Symptoms occurred before the age of 50
- Diagnosed by a neurologist.
Key exclusion criteria (2 listed)
- Children who are <18 years of age
- Any probands who are cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Marder, M.D., M.PH. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.