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Recruiting NCT05010603

Late Onset Alzheimer's Disease

— Observational Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood Draw, Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Genetic Blood Draw
    Collection of blood samples for genetic testing
  • Other Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
    Memory Test

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Family-based

Study locations

United States · 12 centers
  • University of Washington — Washington D.C.
  • University of Miami — Miami
  • Rush University — Aurora
  • Indiana University — Bloomington
  • NCRAD at Indiana University — Indianapolis
  • Mayo Clinic — Rochester
  • Joanne Norton — St Louis
  • Columbia University Irving Medical Center — New York
  • … and 4 more centers

Identifiers

NCT: NCT05010603 · AAAP0479 · 5U24AG056270

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗