Study to Understand Novel Biomarkers in Researching Dementia

NCT06547099 | Recruiting

• 2 other identifiers: 202405156R01AG061900
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

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; Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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; Other: Cognitive assessments

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.

Diagnostic Test: Clinical tau PET; Diagnostic Test: Clinical amyloid test; Other: Research blood collection; Other: Cognitive assessments

Interventions

Clinical tau PET DIAGNOSTIC_TEST

Tau PET (flortaucipir)

Cognitively impaired

Clinical amyloid test DIAGNOSTIC_TEST

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

Cognitively impaired

Research blood collection OTHER

Research blood assays for amyloid, tau, and neurodegeneration

Cognitively impaired; Cognitively normal

Cognitive assessments OTHER

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

Cognitively impaired; Cognitively normal

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 60 years of age
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 37204806 BACKGROUND

• 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.

  PMID: 36087307 BACKGROUND

• 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.

  PMID: 34542571 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, buffy coat, red blood cells

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Randall Bateman, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• David Carr, MD

  Washington University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Lisa Soke

CONTACT

314-747-4857; sunbirdstudy@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)