Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alzheimer's Disease Genetics Study (NCRAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00064870
Recruitment Status : Recruiting
First Posted : July 16, 2003
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Tatiana Foroud, Indiana University

Tracking Information
First Submitted Date July 14, 2003
First Posted Date July 16, 2003
Last Update Posted Date February 28, 2019
Study Start Date June 2002
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2015)
Distribute biological specimens to qualified investigators for use in their research studies. [ Time Frame: Contact investigators annually for an update on progress and publication status. ]
Investigators will analyze the samples and publish de-identified results. These publications will help to further the knowledge in the field of dementia and potentially lead to new therapies and targets for therapies.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alzheimer's Disease Genetics Study
Official Title National Cell Repository for Alzheimer's Disease (NCRAD)
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples
Sampling Method Non-Probability Sample
Study Population Families with two or more members with Alzheimer's disease or dementia
Condition
  • Alzheimer Disease
  • Late Onset Alzheimer Disease
  • Dementia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2005)
3000
Original Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Two living family members diagnosed with AD or other dementia with any age of onset
  • 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
  • Member of a family that was included in the National Institute of Mental Health AD Genetics Sib Pair collection
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Study Coordinator 1-800-526-2839 alzstudy@iupui.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00064870
Other Study ID Numbers IA0042
U24AG021886 ( U.S. NIH Grant/Contract )
NIH grant U24 AG21886
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tatiana Foroud, Indiana University
Study Sponsor Indiana University
Collaborators National Institute on Aging (NIA)
Investigators
Principal Investigator: Tatiana M. Foroud, PhD National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD), Indiana University
PRS Account Indiana University
Verification Date February 2019