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Alzheimer's Disease Genetics Study

Study acronym: NCRAD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years later Jul 2026 → Aug 2031
See other at-risk trials from Indiana University

Amendment history

  1. Notable

    Primary and study completion pushed from Jul 2026 to Aug 2031

    Study Statusv27

  2. Minor

    Study Status, Oversight

    Re-verified, no change to tracked fields

    v26

  3. Minor

    Site details revised

    Study Status, Eligibility, Contacts/Locationsv25

  4. Minor

    2 amendments

    2 re-verifications since 2024-03-07, no change to tracked fields

    v23-v24

  5. Notable

    Enrollment target: 3000 to 10000

    Study Identification, Study Status, Study Designv22

Show 20 earlier versions

  1. Notable

    Primary and study completion dates: Jul 2021 to Jul 2026

    Study description revised; Site contact updated

    Show what changed: Study description
    [...] t the privacy rights of study participants before receiving DNAsamples and data.

    Study Status, Study Description, Study Design, Contacts/Locations, Referencesv21

  2. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v20

  3. Minor

    Site details revised

    Study Status, Contacts/Locationsv19

  4. Minor

    2 amendments

    2 re-verifications since 2016-08-29, no change to tracked fields

    v17-v18

  5. Notable

    Primary and study completion dates: Jun 2016 to Jul 2021

    Study Statusv16

  6. Minor

    Site details revised

    Study Identification, Study Status, Outcome Measures, Contacts/Locationsv15

  7. Minor

    Study Status

    Re-verified, no change to tracked fields

    v14

  8. Minor

    Primary and study completion dates: Sep 2016 to Jun 2016

    Study Status, Oversightv13

  9. Notable

    Primary and study completion dates: Jun 2011 to Sep 2016

    Site contact updated

    Study Status, Sponsor/Collaborators, Contacts/Locationsv12

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  11. Notable

    Lead sponsor: National Institute on Aging (NIA) to Indiana University

    Primary and study completion dates: May 2010 to Jun 2011; Eligibility criteria shortened, about 20 words; Study description shortened, about 299 words; and 1 more

    Show all 5 changes in this update
    • Notable Lead sponsor: National Institute on Aging (NIA) to Indiana University
    • Notable Primary and study completion dates: May 2010 to Jun 2011
    • Minor Eligibility criteria shortened, about 20 words
      Show what changed
      Inclusion Criteria: Two living family members diagnosed with AD or other dementia with any age of onset At least one other affected or unaffected relative willing to participate Biological samples available Fresh blood, or Immortalized ly [...] mbers. 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
    • Minor Study description shortened, about 299 words
      Show what changed
      The purpose of the Alzheimer's Disease Genetics Study is to help identify the genes that aremay be 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 [...] [...]
    • Minor Collaborators expanded, about 5 words
      Show what changed
      National Institute on Aging (NIA)

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Eligibilityv10

  12. Minor

    2 amendments

    2 re-verifications since 2009-01-29, no change to tracked fields

    v8-v9

  13. Minor

    Primary completion date: May 2010

    Completion date: May 2008 to May 2010; Eligibility criteria shortened, about 206 words; Study description expanded, about 2 words; and 1 more

    Show all 5 changes in this update
    • Minor Primary completion date: May 2010
    • Minor Completion date: May 2008 to May 2010
    • Minor Eligibility criteria shortened, about 206 words
      Show what changed
      Inclusion Criteria: Families meeting the criteria will have aTwo living siblingfamily pairmembers diagnosed with AD with an onsetany age of 60 or older and atonset At least one other affected or unaffected relative willing to participate. There must be at least three individuals in the family for whom biological samples are available. First Family Member (proband): A diagnosis of Definite or Probable AD by NINDS-ADRDA criteria. Age at onset or age at diagnosis of > 60 years. Individual was evaluated in person and diagnosed by an NI [...] Biological samples available. Second Family Member: A sibling [...] [...]
    • Minor Study description expanded, about 2 words
      Show what changed
      [...] r 60 years of age). Families meeting the criteria will have aany two living siblingfamily pairmembers diagnosed with AD with an onset of age 60 or older and at l [...] ill have a minimum of 3 members participating in the study: aany two living siblingfamily pairmembers diagnosed with AD with an onset at age 60 or older and a th [...]
    • Minor Site contact updated

    Study Status, Sponsor/Collaborators, Study Description, Study Design, Eligibility, Contacts/Locationsv7

  14. Minor

    Eligibility criteria expanded, about 38 words

    Study description expanded, about 34 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Families meeting the criteria will have a living sibling pair diagnosed with AD with an onset age of 60 or o [...] s 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 k [...]
    Show what changed: Study description
    [...] om families with multiple members diagnosed with late onset AD (over 60 years of age). Families meeting the criteria will have a living sibling pair 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 oth [...] ll have a minimum of 3 members participating in the study: a living sibling pair diagnosed with AD with an onset at age 60 or o [...]

    Study Status, Study Description, Study Design, Eligibility, Contacts/Locationsv6

  15. Minor

    3 amendments

    3 re-verifications since 2005-09-19, no change to tracked fields

    v3-v5

  16. Minor

    Completion date: May 2005 to May 2008

    Study Statusv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Indiana University
310 trials monitored
See 40 trials at risk
Alzheimer's Disease
1,152 trials monitored
See 60 trials at risk
Dementia
920 trials monitored
See 46 trials at risk
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.
Trial Details
NCT Number NCT00064870
Lead Sponsor Indiana University
Collaborators: National Institute on Aging (NIA)
Conditions Alzheimer Disease, Late Onset Alzheimer Disease, Dementia
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov