Late Onset Alzheimer's Disease

Alzheimer Disease Clinical Trial

— LOAD  

Official title:

Late Onset Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010603
• Other study ID #: AAAP0479
• Secondary ID: 1U24AG056270
• Status: Recruiting
• Start date: November 15, 2016
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Dolly Reyes-Dumeyer
• Phone: 212-305-5953
• Email: dr2290[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Genetic:
• Blood Draw
Collection of blood samples for genetic testing

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

Locations

Country	Name	City	State
United States	Rush University	Aurora	Illinois
United States	Indiana University	Bloomington	Indiana
United States	University of Texas Southwestern	Dallas	Texas
United States	NCRAD at Indiana University	Indianapolis	Indiana
United States	University of Miami	Miami	Florida
United States	Columbia University Irving Medical Center	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	North Carolina State University	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Joanne Norton	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	University of Washington	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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