Alzheimer DiseaseSUNBIRDNCT06547099
Study to Understand Novel Biomarkers in Researching Dementia
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- Clinical tau PET, Clinical amyloid test and Research blood collection
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lisa Soke, 314-747-4857, sunbirdstudy@wustl.edu
Randall Bateman, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Being tested
- Clinical tau PET, Clinical amyloid test, Research blood collection, Cognitive assessments
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical tau PETDiagnostic test
Tau PET (flortaucipir)
Clinical amyloid testDiagnostic test
Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
Research blood collectionOther
Research blood assays for amyloid, tau, and neurodegeneration
Cognitive assessmentsOther
Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Clinical tau PET; Diagnostic Test: Clinical amyloid test; Other: Research blood collection; Other: Cognitive assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status
Measured: Baseline
Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status
Measured: Baseline
Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status
Measured: Baseline
Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis
Measured: 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
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes (6)
Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status
Measured: Baseline
Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status
Measured: Baseline
Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma eMTBR-243 in predicting tau PET status
Measured: Baseline
Area under the curve (AUC) of plasma eMTBR-243 in predicting clinical diagnosis
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Aug 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Randall Bateman, MD, Principal investigator, Washington University School of MedicineDavid Carr, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547099
- Sponsor's protocol ID
- 202405156
- Other IDs
- R01AG061900
- Acronym
- SUNBIRD
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37204806Janelidze 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.
PubMed 36087307Janelidze 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.
PubMed 34542571
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis
- ClinicalTrials.gov ID
- NCT06547099
- Acronym / sponsor ID
- SUNBIRD / 202405156
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal | – | Other: Research blood collection, Other: Cognitive assessmentsParticipants without symptoms of cognitive impairment will be followed up annually for potential cognitive changes, and will complete additional blood collections every two years. |
| Cognitively impaired | – | Diagnostic Test: Clinical tau PET, Diagnostic Test: Clinical amyloid test, Other: Research blood collection, Other: Cognitive assessmentsFor 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical tau PETTau PET (flortaucipir) | Diagnostic test | Cognitively impaired |
| Clinical amyloid testAmyloid PET (florbetapir), CSF amyloid test, or blood amyloid test | Diagnostic test | Cognitively impaired |
| Research blood collectionResearch blood assays for amyloid, tau, and neurodegeneration | Other | Cognitively impaired, Cognitively normal |
| Cognitive assessmentsClinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA) | Other | Cognitively impaired, Cognitively normal |
Primary outcome
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-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
6 secondary outcomes
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 neurofilament light in predicting clinical diagnosis
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma eMTBR-243 in predicting tau PET status
Time frame: Baseline
Area under the curve (AUC) of plasma eMTBR-243 in predicting clinical diagnosis
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 37204806Li 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.
- Background: PubMed 36087307Janelidze 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.
- Background: PubMed 34542571Janelidze 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randall Bateman, MD principal investigator
Washington University School of Medicine
David Carr, MD study director
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Soke (314-747-4857, sunbirdstudy@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547099, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.