Study to Understand Novel Biomarkers in Researching Dementia (SUNBIRD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Other: Research blood collection; Other: Cognitive assessments; Diagnostic test: Clinical tau PET; Diagnostic test: Clinical amyloid test

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

• Study Contact: Name: Lisa Soke; Phone Number: 314-747-4857; Email: sunbirdstudy@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Principal Investigator: Randall Bateman, MD
      • Contact: Lisa Soke; Phone Number: 314-747-4857; Email: sunbirdstudy@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All participants who completed our prior study, the Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD, NCT03899844), will be invited to join SUNBIRD. We will also recruit approximately 1000 new participants from Washington University and Barnes-Jewish Hospital affiliated clinics in the greater St. Louis metropolitan area.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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)
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.	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); Diagnostic test: Clinical tau PET; Tau PET (flortaucipir); Diagnostic test: Clinical amyloid test; Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status	Baseline
Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status	Baseline
Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status	Baseline
Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status	Baseline
Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status	Baseline
Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis	Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis	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	Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis	Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Randall Bateman, MD, Washington University School of Medicine; Study Director: David Carr, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Li M, Li Y, Schindler SE, Yen D, Sutcliffe S, Babulal GM, Benzinger TLS, Lenze EJ, Bateman RJ. Design and feasibility of an Alzheimer's disease blood test study in a diverse community-based population. Alzheimers Dement. 2023 Dec;19(12):5387-5398. doi: 10.1002/alz.13125. Epub 2023 May 19.
• Janelidze S, Bali D, Ashton NJ, Barthelemy NR, Vanbrabant J, Stoops E, Vanmechelen E, He Y, Dolado AO, Triana-Baltzer G, Pontecorvo MJ, Zetterberg H, Kolb H, Vandijck M, Blennow K, Bateman RJ, Hansson O. Head-to-head comparison of 10 plasma phospho-tau assays in prodromal Alzheimer's disease. Brain. 2023 Apr 19;146(4):1592-1601. doi: 10.1093/brain/awac333.
• Janelidze S, Teunissen CE, Zetterberg H, Allue JA, Sarasa L, Eichenlaub U, Bittner T, Ovod V, Verberk IMW, Toba K, Nakamura A, Bateman RJ, Blennow K, Hansson O. Head-to-Head Comparison of 8 Plasma Amyloid-beta 42/40 Assays in Alzheimer Disease. JAMA Neurol. 2021 Nov 1;78(11):1375-1382. doi: 10.1001/jamaneurol.2021.3180.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Dementia
• Other Study ID Numbers: 202405156; R01AG061900 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified blood biomarker, clinical cognitive assessment, PET, and demographic data will be made available for sharing in the LONI IDA repository. Genetic data (genome-wide associated studies) will be made available in the dbGaP repository.
• IPD Sharing Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data is subject to policies followed by dbGaP and LONI IDA repositories.
• IPD Sharing Access Criteria: Given the sensitive nature of the dataset, data will be made available in LONI IDA and dbGaP data repositories, which restrict access to the data to qualified investigators with an approved data use agreement (DUA). Data can be accessed after application and approval through the LONI IDA and dbGaP databases.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No