Health TrialsbyHealthPanel

Study to Understand Novel Biomarkers in Researching Dementia

ConditionsAlzheimer DiseaseMild Cognitive ImpairmentDementia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

    Research blood assays for amyloid, tau, and neurodegeneration

  • Cognitive assessments

    Other intervention

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

Treatment groups

1,800 Participants
are divided into 2 treatment groups
Group A: Cognitively normal2 interventions
Group B: Cognitively impaired4 interventions

Trial outcomes

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-tau217 in predicting clinical diagnosis

Time frame
Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary outcomes

1

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

Time frame
Baseline
2

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

Time frame
Baseline
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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