RecruitingNCT06547099

Study to Understand Novel Biomarkers in Researching Dementia

Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis


Sponsor

Washington University School of Medicine

Enrollment

1,800 participants

Start Date

Aug 14, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 Years

Inclusion Criteria3

  • At least 60 years of age
  • % 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 Criteria5

  • 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

Interventions

DIAGNOSTIC_TESTClinical tau PET

Tau PET (flortaucipir)

DIAGNOSTIC_TESTClinical amyloid test

Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test

OTHERResearch blood collection

Research blood assays for amyloid, tau, and neurodegeneration

OTHERCognitive assessments

Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06547099


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