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

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
Alzheimer Disease
Late Onset Alzheimer Disease

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Alzheimer's Disease Genetics Study

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

blood samples


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)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Families with two or more members with Alzheimer's disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064870

Contacts
Contact: Study Coordinator 1-800-526-2839 alzstudy@iupui.edu

Locations
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    
Sponsors and Collaborators
Investigators
Principal Investigator: Tatiana M. Foroud, PhD National Cell Repository for Alzheimer's Disease (NCRAD), Indiana University
  More Information

Additional Information:
No publications provided

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: January 29, 2009
ClinicalTrials.gov Identifier: NCT00064870     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Late Onset Alzheimer disease risk factor genes
Genetics
Initiative

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 09, 2009