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Alzheimer's Disease Genetics Study
This study is currently recruiting participants.
Study NCT00064870   Information provided by National Institute on Aging (NIA)
First Received: July 14, 2003   Last Updated: January 29, 2009   History of Changes

July 14, 2003
January 29, 2009
June 2002
May 2010   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00064870 on ClinicalTrials.gov Archive Site
 
 
 
Alzheimer's Disease Genetics Study
Alzheimer's Disease Genetics Study

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).

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.

 
Observational
Cohort, Prospective
  • Alzheimer Disease
  • Late Onset Alzheimer Disease
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3000
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Two living family members diagnosed with AD with any age of onset
  • At least one other affected or unaffected relative willing to participate
  • Biological samples available

    • Fresh blood, or
    • Immortalized lymphoblastic cell lines, or
    • 3-5 grams of frozen cerebral cortex; fixed samples are not accepted

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:

  • Does not meet inclusion criteria
  • Has a known mutation in an early onset AD autosomal dominant gene
  • Member of a family that was included in the National Institute of Mental Health AD Genetics Sib Pair collection
Both
 
Yes
Contact: Study Coordinator 1-800-526-2839 alzstudy@iupui.edu
United States
 
NCT00064870
Tatiana M Foroud, National Cell Repository for Alzheimer's Disease (NCRAD)
IA0042, NIH grant U24 AG21886
National Institute on Aging (NIA)
 
Principal Investigator: Tatiana M. Foroud, PhD National Cell Repository for Alzheimer's Disease (NCRAD), Indiana University
National Institute on Aging (NIA)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP