Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2003 | ||||
| Last Updated Date | June 25, 2012 | ||||
| Start Date ICMJE | August 2002 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00051324 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neurobiological Predictors of Huntington's Disease (PREDICT-HD) | ||||
| Official Title ICMJE | Neurobiological Predictors of Huntington's Disease Trial | ||||
| Brief Summary | The purpose of this trial is to study early brain and behavioral changes in people who have the gene expansion for Huntington's disease, but are currently healthy and have no symptoms. |
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| Detailed Description | Huntington's Disease (HD) is an inherited disease that causes changes in a person's ability to control movements, thinking, and feelings. The intent of this study is to learn more about the beginning changes in thinking skills, emotional regulation, and brain structure and function as a person begins the transition from health to HD. Preliminary studies indicate that people with HD may have marked decline before an actual diagnosis. This study will help reveal the earliest indicators of the disease and what factors influence the age at which a person carrying the gene develops the disease. It is necessary to get information on the early stages of HD in order to develop drugs that can slow or postpone the onset of HD. The investigators hope this study will provide essential information for future trials of experimental drugs for HD. During this study, participants will undergo several detailed tests, including MRI scans of the brain, cognitive assessments, physical exams, and neurological and psychiatric testing. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Plasma retained from 2000-2007. Urine, plasma and cell lines to be acquired and retained 2008-2013. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD. |
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| Condition ICMJE | Huntington Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | 1500 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion 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, Australia, Canada, Germany, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00051324 | ||||
| Other Study ID Numbers ICMJE | R01NS040068, R01NS040068 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jane S. Paulsen, University of Iowa | ||||
| Study Sponsor ICMJE | University of Iowa | ||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Iowa | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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