NCT06547099 · Washington University School of Medicine
Study to Understand Novel Biomarkers in Researching Dementia
(SUNBIRD)
What this study is about
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.
View original scientific description
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.
Interventions
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)
Primary outcome measures
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-tau205 in predicting tau PET status
Time frame: Baseline
Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status
Time frame: Baseline
Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
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
Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St Louis, Missouri
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations