Alzheimer's Disease Genetics Study
| Tracking Information | |||||
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| First Received Date ICMJE | July 14, 2003 | ||||
| Last Updated Date | April 3, 2013 | ||||
| Start Date ICMJE | June 2002 | ||||
| Estimated Primary Completion Date | June 2016 (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 NCT00064870 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 | Alzheimer's Disease Genetics Study | ||||
| Official Title ICMJE | Alzheimer's Disease Genetics Study | ||||
| Brief Summary | The purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor genes for late onset AD can be investigated is by identifying and collecting genetic material from families with multiple members diagnosed with AD or dementia. |
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| Detailed Description | The purpose of the Alzheimer's Disease Genetics Study is to help identify the genes that may be responsible for causing Alzheimer's Disease (AD) by collecting genetic material from families with multiple members diagnosed with AD. Qualifying families will have two living blood-related individuals who have been diagnosed with or are showing symptoms of AD or dementia. Local study sites are located all over the United States, and arrangements may be made for eligible families who do not live near a participating site. The biological samples and data from these families will be made available to qualified researchers, who must sign a Materials Transfer Agreement (MTA) in order to protect the privacy rights of study participants before receiving DNA and data. |
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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: blood samples |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Families with two or more members with Alzheimer's disease or dementia |
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| Condition ICMJE |
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| 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 | 3000 | ||||
| Estimated Completion Date | June 2016 | ||||
| Estimated Primary Completion Date | June 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Please note: this study does not include genetic counseling; because no personal identifying information such as name or date of birth is attached to samples, results of individual tests are not available to participants or family members. Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00064870 | ||||
| Other Study ID Numbers ICMJE | IA0042, U24AG021886, NIH grant U24 AG21886 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Indiana University | ||||
| Study Sponsor ICMJE | Indiana University | ||||
| Collaborators ICMJE | National Institute on Aging (NIA) | ||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||
| Verification Date | April 2013 | ||||
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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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