Study to Understand Novel Biomarkers in Researching Dementia

Purpose

The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.

Conditions

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Dementia

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • At least 60 years of age - 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and/or provider - All SEABIRD participants will be invited to participate regardless of their cognitive status

Exclusion Criteria

  • Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment - Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection - Taking a disease-modifying drug for AD at time of enrollment - Blood transfusion in the last three months - Unwilling or unable to participate in all study activities

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cognitively normal Participants without symptoms of cognitive impairment will be followed up annually for potential cognitive changes, and will complete additional blood collections every two years.
  • Other: Research blood collection
    Research blood assays for amyloid, tau, and neurodegeneration
  • Other: Cognitive assessments
    Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
Cognitively impaired For participants with symptoms of cognitive impairment, their medical providers will review the results of the research cognitive assessments and determine whether further testing (a clinical tau PET scan and choice of an amyloid PET, cerebrospinal fluid, or blood clinical test for amyloid plaques) is needed. Symptomatic participants will be followed up annually for research blood collections and cognitive assessments.
  • Diagnostic Test: Clinical tau PET
    Tau PET (flortaucipir)
  • Diagnostic Test: Clinical amyloid test
    Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
  • Other: Research blood collection
    Research blood assays for amyloid, tau, and neurodegeneration
  • Other: Cognitive assessments
    Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Lisa Soke
314-747-4857
sunbirdstudy@wustl.edu

More Details

NCT ID
NCT06547099
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Lisa Soke
314-747-4857
sunbirdstudy@wustl.edu

Detailed Description

All participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. Depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for Alzheimer's disease as determined by the participant's medical provider.