Clinical trial NCT05010603: Late Onset Alzheimer's Disease
Official title: Late Onset Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Keywords: Genetic testing
Genetic influence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Total number of genes identified to be associated with the risk of AD
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: University of Washington
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Aurora
country: United States
facility: Rush University
state: Illinois
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: NCRAD at Indiana University
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Joanne Norton
state: Missouri
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Raleigh
country: United States
facility: North Carolina State University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Columbia University
name: Richard P. Mayeux, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: