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NCT Number: NCT06547099

Study to Understand Novel Biomarkers in Researching Dementia

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Lisa Soke

CONTACT

[email protected]

314-747-4857

Randall Bateman, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical tau PET

Diagnostic Test

Tau PET (flortaucipir)

Clinical amyloid test

Diagnostic Test

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

Research Blood Collection

Other

Research blood assays for amyloid, tau, and neurodegeneration

Cognitive assessments

Other

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

Primary outcomes

  1. Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status

    Time frame: Baseline

  2. Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status

    Time frame: Baseline

  3. Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status

    Time frame: Baseline

  4. Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status

    Time frame: Baseline

  5. Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status

    Time frame: Baseline

  6. 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

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Soke

CONTACT

[email protected]

314-747-4857

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SUNBIRD

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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