Recruiting

Genetic Influences

Sponsor:

Columbia University

Code:

NCT05010603

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Blood Draw

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

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT05010603

Start date

Nov 15, 2016

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Families with a history of Alzheimer's Disease

Families with two or more family members affected with Alzheimer's Disease

Un-related, non-demented controls

Un-related, non-demented healthy controls over age 55

Individuals with Dementia (Alzheimer's Disease)

Individuals with dementia over the age of 65

Interventions

Blood Draw

Collection of blood samples for genetic testing

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

Memory Test

Primary outcome measure

  • Total number of genes identified to be associated with the risk of AD [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

University of Washington

Recruiting

Washington D.C., District of Columbia, United States, 98105

University of Miami

Recruiting

Miami, Florida, United States, 33124

Rush University

Recruiting

Aurora, Illinois, United States, 60612

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

NCRAD at Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Joanne Norton

Recruiting

St Louis, Missouri, United States, 63130

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Richard P Mayeux, MD, MSc

North Carolina State University

Recruiting

Raleigh, North Carolina, United States, 27695

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Columbia University

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Genetic testing
  • Genetic influence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-18.