Understanding Biomarkers in Alzheimer's Disease and Dementia

This observational study aims to understand how well blood tests can detect and predict Alzheimer's disease (AD) and related conditions like mild cognitive impairment (MCI) and dementia. Researchers are looking at the relationship between specific markers in the blood (amyloid, tau, and signs of neurodegeneration) and the presence of AD in the brain, as well as changes in thinking and memory. You might receive tests like a tau PET scan (using flortaucipir), an amyloid PET scan (using florbetapir), or blood/spinal fluid tests for amyloid. The study will measure how accurately blood tests for amyloid-beta 42/40 and p-tau217 predict the results of amyloid and tau PET scans. People aged 60 and older, with or without memory issues, can join this study, which plans to enroll 1800 participants.

Study design
This is an observational study, not testing a new treatment, and plans to include 1800 participants. It is not specified if participants are randomly assigned to groups or if the study is blinded.
What's involved
You will have an initial visit for blood collection and cognitive assessments. Depending on your cognitive assessment results, you may have follow-up visits annually or every two years for more cognitive tests, blood collections, and potential clinical tests for Alzheimer's disease.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06547099

Study to Understand Novel Biomarkers in Researching Dementia

Recruiting
Not specifiedAges 60+Observational
Washington University School of Medicine
~1,800 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:Clinical tau PETClinical amyloid testResearch blood collectionCognitive assessments

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status
Measured over Baseline
+8 more outcomes measured
Alzheimer Disease
Mild Cognitive Impairment
Dementia
1 sites across 1 states
Missouri1
  • Randall Bateman, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • David Carr, MD · STUDY_DIRECTOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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
  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET statusBaseline
  • Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET statusBaseline
  • Area under the curve (AUC) of plasma p-tau217 in predicting tau PET statusBaseline
  • Area under the curve (AUC) of plasma p-tau205 in predicting tau PET statusBaseline
  • Area under the curve (AUC) of plasma neurofilament light in predicting tau PET statusBaseline
  • Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosisBaseline, 1 year, 2 years, 3 years, 4 years, 5 years
  • Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosisBaseline, 1 year, 2 years, 3 years, 4 years, 5 years
  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosisBaseline, 1 year, 2 years, 3 years, 4 years, 5 years
  • Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosisBaseline, 1 year, 2 years, 3 years, 4 years, 5 years