Recruiting

Biomarkers

Sponsor:

Washington University School of Medicine

Code:

NCT06547099

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Dementia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Clinical tau PET

Clinical amyloid test

Research blood collection

Cognitive assessments

Study Details

Brief 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.

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Dementia

Study ID

NCT06547099

Start date

Aug 14, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Enrollment

1800 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Clinical tau PET

Tau PET (flortaucipir)

Clinical amyloid test

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

Research blood collection

Research blood assays for amyloid, tau, and neurodegeneration

Cognitive assessments

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

Primary outcome measure

  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status [ Time Frame: Baseline ]
  • Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status [ Time Frame: Baseline ]
  • Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status [ Time Frame: Baseline ]
  • Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis [ Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years ]
  • Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis [ Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years ]

Central Contacts and Locations

Central contacts

Lisa Soke

314-747-4857sunbirdstudy@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Lisa Soke

314-747-4857sunbirdstudy@wustl.edu

Principal Investigator:

Randall Bateman, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.