Twins and the Risk of Parkinson's Disease: A Clinical and Imaging Study
Recruitment status was Active, not recruiting
|First Received Date ICMJE||January 26, 2006|
|Last Updated Date||July 1, 2009|
|Start Date ICMJE||April 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Onset of Parkinson's disease [ Time Frame: duration of the project ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00282802 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Age of Parkinson's disease onset [ Time Frame: duration of the project ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Twins and the Risk of Parkinson's Disease: A Clinical and Imaging Study|
|Official Title ICMJE||Twins and the Risk of PD: A Clinical and Imaging Study|
The purpose of this study is to examine the role of genetic and environmental factors in the cause of Parkinson's disease.
Parkinson's disease (PD) is a growing health problem in the elderly, and genetic factors may provide substantial clues toward eventual treatment and/or prevention of the disorder. The National Academy of Sciences/National Resource Council (NAS/NRC) World War II (WWII) Veteran Twins Cohort Registry is one of the few population-based groups of elderly twins. Previous studies in this group indicated that genetic factors were involved only in early-onset PD, however there was no follow-up to these studies.
The purpose of the "Twins and the Risk of PD" study is to follow-up previous studies and confirm the initial findings. In this study, investigators will use the NAS/NRC WWII Veteran Twin Cohort Registry to compare the concordance rates for PD in monozygotic and dizygotic twins—at least one of whom has PD.
The overall goal of this research is determine the contributions of genetic and environmental factors in the cause of PD.
The study will involve traditional clinical research methods, such as a clinical examination, as well as innovative imaging techniques, such as single photon emission computed tomography (SPECT). SPECT—a nuclear imaging test involving blood flow to tissue—is used to evaluate certain brain functions.
Findings from this study may help to set research priorities in PD, and to develop tools for early detection of the disorder.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
Participants will be recruited from a closed cohort—the National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort
|Condition ICMJE||Parkinson's Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||1
National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||250|
|Estimated Completion Date||July 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||77 Years to 88 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00282802|
|Other Study ID Numbers ICMJE||R01NS40467, R01 NS 40467-01|
|Has Data Monitoring Committee||No|
|Responsible Party||Caroline M. Tanner, MD, PhD, Director of Clinical Research, The Parkinson's Institute|
|Study Sponsor ICMJE||The Parkinson's Institute|
|Collaborators ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Information Provided By||The Parkinson's Institute|
|Verification Date||July 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP