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Late Onset Alzheimer's Disease (LOAD)

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: NCT05010603
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Columbia University

Study Description
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Brief Summary:
The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.

Condition or disease Intervention/treatment
Alzheimer Disease Genetic: Blood Draw Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test

Detailed Description:
The purpose of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. Specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-E (APOE), or the 3 genes associated with early-onset familial AD, presenilin-1 (PS-1), presenilin-2 (PS-2) or B-amyloid precursor protein (APP), increase the risk of AD in families with multiple individuals affected with AD. The investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease. In addition, the investigators will study genes known to increase the risk of Alzheimer's disease and other related disorders such as early onset AD, Pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and Lewy Body Dementia.
Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Late Onset Alzheimer's Disease
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Families with a history of Alzheimer's Disease
Families with two or more family members affected with Alzheimer's Disease
 Genetic: Blood Draw
Collection of blood samples for genetic testing

Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
Memory Test
Un-related, non-demented controls
Un-related, non-demented healthy controls over age 55
 Genetic: Blood Draw
Collection of blood samples for genetic testing

Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
Memory Test
Individuals with Dementia (Alzheimer's Disease)
Individuals with dementia over the age of 65
 Genetic: Blood Draw
Collection of blood samples for genetic testing

Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
Memory Test


Outcome Measures
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Primary Outcome Measures :
  1. Total number of genes identified to be associated with the risk of AD [ Time Frame: 5 years ]
    Genetic Linkage Analysis to Identify Genes Associated with the risk of Alzheimer's Disease: Identification of genes by performing genetic linkage analysis, in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease.


Biospecimen Retention:   Samples With DNA
Blood and samples from autopsy/brain tissue.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators intend to recruit individuals from: 1) community-based studies; 2) the Alzheimer's Disease Research Center Memory Disorders Center; 3) the private offices of the study neurologists; 4) public recruitment; 5) referrals from the Alzheimer's Association; 6) referrals from the NCRAD; 7)previously unidentified members of existing families not previously recruited. The investigators will also use advertisements such as radio, television and newspapers.
Criteria

Inclusion Criteria:

  • Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.
  • a living sibling with probable or possible AD;
  • a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);
  • participants in the proband's generation with an identified companion serving as an informant;
  • participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.

Exclusion Criteria:

  • failure to identify an appropriate informant;
  • uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;
  • discovery of additional diagnosis that could account for the clinical manifestations;
  • unwillingness to participate;
  • failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);
  • participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010603


Contacts
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Contact: Izri Martinez Soto 212-305-0865 imm2129@cumc.columbia.edu
Contact: Dolly Reyes-Dumeyer dr2290@cumc.columbia.edu

Locations
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United States, District of Columbia
University of Washington Recruiting
Washington, District of Columbia, United States, 98105
Contact: Sarah Payne         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33124
Contact: Larry Deon         
United States, Illinois
Rush University Recruiting
Aurora, Illinois, United States, 60612
Contact: Corey Woods         
United States, Indiana
Indiana University Recruiting
Bloomington, Indiana, United States, 47405
Contact: Kelly Farber         
NCRAD at Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kelly Farber         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Christine Hanzel         
United States, Missouri
Joanne Norton Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Joanne Norton         
United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Izri Martinez Soto    212-305-0865    imm2129@cumc.columbia.edu   
United States, North Carolina
North Carolina State University Recruiting
Raleigh, North Carolina, United States, 27695
Contact: Takiyah Starks         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elise Weamer         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Amy Browning         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Columbia University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Richard P. Mayeux, MD, MSc Columbia University
More Information
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT05010603    
Other Study ID Numbers: AAAP0479
1U24AG056270 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is stored in a secured database at Columbia University and de-identified data will be sent to the National Cell Repository for Alzheimer's disease. DNA will be stored at the National Cell Repository for Alzheimer's disease (NCRAD) at Indiana University. In addition to the blood sample, year of birth, family history of dementia, and diagnosis will be sent to NCRAD. DNA and associated clinical and demographic data will be made available to qualified and approved researchers studying the genetics of AD, aging, and related disorders. If the participant agrees, his/her de-identified samples and data will be made available to investigators studying the genetics of any human disease. Identity of participants will not be shared with NCRAD or with any investigators.
Supporting Materials: Study Protocol
Time Frame: The data is currently available
Access Criteria: When requesting samples to NCRAD the "Master Agreement for Transfer of Materials to NCRAD" and related Appendix A must be completed prior to the transfer of any samples. The Master Material Transfer Agreement (MTA) agreement is between the Institutions and is not Investigator specific. Therefore, if you think your Institution may already have a Master MTA in place with NCRAD.
URL: https://osp.od.nih.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia University:
Genetic testing
Genetic influence
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders