LOAD: Late Onset Alzheimer's Disease

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05010603
Collaborator
National Institute on Aging (NIA) (NIH)
10,000
12
117.5
833.3
7.1

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Late Onset Alzheimer's Disease
Actual Study Start Date :
Nov 15, 2016
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Total number of genes identified to be associated with the risk of AD [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of Washington Washington District of Columbia United States 98105
2 University of Miami Miami Florida United States 33124
3 Rush University Aurora Illinois United States 60612
4 Indiana University Bloomington Indiana United States 47405
5 NCRAD at Indiana University Indianapolis Indiana United States 46202
6 Mayo Clinic Rochester Minnesota United States 55901
7 Joanne Norton Saint Louis Missouri United States 63130
8 Columbia University Irving Medical Center New York New York United States 10032
9 North Carolina State University Raleigh North Carolina United States 27695
10 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
11 University of Texas Southwestern Dallas Texas United States 75390
12 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • Columbia University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Richard P. Mayeux, MD, MSc, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT05010603
Other Study ID Numbers:
  • AAAP0479
  • 1U24AG056270
First Posted:
Aug 18, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021