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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00064870 |
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 late onset AD (over 60 years of age).
Condition |
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Alzheimer Disease Late Onset Alzheimer Disease |
Study Type: | Observational |
Official Title: | Alzheimer's Disease Genetics Study |
Estimated Enrollment: | 3000 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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 late onset AD (over 60 years of age). Families meeting the criteria will have any two living family members diagnosed with AD with an onset of age 60 or older and at least one other affected or unaffected relative willing to participate. Families will be evaluated for a medical diagnosis and other factors. If eligible, blood samples will be collected from the participants to establish cell lines. If one of the identified family members is deceased, DNA will be extracted and stored from autopsy samples. Qualifying families will have a minimum of 3 members participating in the study: any two living family members diagnosed with AD with an onset at age 60 or older and a third member who must have an age of onset greater than 50, if affected, and 60 or older, if unaffected. The goal is to recruit 1,000 families in three years. This research will include a collection of samples from ethnic/minority populations and other special populations, including African Americans, the Amish, Hispanics, Asian Americans, and Japanese-Americans. Persons interested in registering to participate in this study can call the toll-free NCRAD number 1-800-526-2839 for more information. 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.
Local sites, including the NIA-sponsored Alzheimer's Disease Centers, will collect clinical and demographic data from these families, and the sites will send coded data (without identifiers) to the National Cell Repository for Alzheimer's Disease (NCRAD) at Indiana University. The biological samples and data from these families will be available to qualified researchers, who must sign a Materials Transfer Agreement (to protect the privacy rights of participants in this study and to agree to share the results of genetic analyses) before receiving DNA and data. An oversight committee known as the Cell Bank Advisory Committee (CBAC) and the Coordinator of the NIA Alzheimer's Disease Genetics Study, Richard Mayeux, MD, Columbia University, will review and monitor the process of family identification and enrollment, data collection, and the establishment of cell lines. This repository of DNA and cell lines was developed in hopes of discovering risk factor genes that contribute to late onset AD.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Biological samples available
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:
Contact: Study Coordinator | 1-800-526-2839 | alzstudy@iupui.edu |
United States, Indiana | |
Participants are being recruited from all over the United States | Recruiting |
Nationwide, Indiana, United States | |
Contact: NCRAD Study Coordinator 800-526-2839 alzstudy@iupui.edu | |
Contact: Spanish-speaking Contact 800-243-5828 vcs2103@columbia.edu |
Principal Investigator: | Tatiana M. Foroud, PhD | National Cell Repository for Alzheimer's Disease (NCRAD), Indiana University |
Responsible Party: | National Cell Repository for Alzheimer's Disease (NCRAD) ( Tatiana M Foroud ) |
Study ID Numbers: | IA0042, NIH grant U24 AG21886 |
Study First Received: | July 14, 2003 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00064870 |
Health Authority: | United States: Federal Government |
Alzheimer disease Late Onset Alzheimer disease risk factor genes Genetics Initiative |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Alzheimer disease type 2 Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |