NCT05010603

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2016Apr 2027

Study Start

First participant enrolled

November 15, 2016

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

10.5 years

First QC Date

August 11, 2021

Last Update Submit

May 15, 2026

Conditions

Keywords

Genetic testingGenetic influence

Outcome Measures

Primary Outcomes (1)

  • Total number of genes identified to be associated with the risk of AD

    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.

    5 years

Study Arms (3)

Families with a history of Alzheimer's Disease

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

Genetic: Blood DrawOther: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test

Un-related, non-demented controls

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

Genetic: Blood DrawOther: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test

Individuals with Dementia (Alzheimer's Disease)

Individuals with dementia over the age of 65

Genetic: Blood DrawOther: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test

Interventions

Blood DrawGENETIC

Collection of blood samples for genetic testing

Families with a history of Alzheimer's DiseaseIndividuals with Dementia (Alzheimer's Disease)Un-related, non-demented controls

Memory Test

Families with a history of Alzheimer's DiseaseIndividuals with Dementia (Alzheimer's Disease)Un-related, non-demented controls

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Washington

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

RECRUITING

University of Miami

Miami, Florida, 33124, United States

RECRUITING

Rush University

Aurora, Illinois, 60612, United States

RECRUITING

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

NCRAD at Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

Joanne Norton

St Louis, Missouri, 63130, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

North Carolina State University

Raleigh, North Carolina, 27695, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and samples from autopsy/brain tissue.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Richard P. Mayeux, MD, MSc

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

November 15, 2016

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.
More information

Locations