Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD)
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ClinicalTrials.gov Identifier: NCT03899844 |
Recruitment Status :
Recruiting
First Posted : April 2, 2019
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment |
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Alzheimer Disease Alzheimer Dementia | Other: Blood collection, PiB PET/MRI, and cognitive testing |
Study Type : | Observational |
Estimated Enrollment : | 1120 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta |
Actual Study Start Date : | April 9, 2019 |
Estimated Primary Completion Date : | August 2023 |
Estimated Study Completion Date : | August 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Cognitively normal
896 of the 1120 enrolled will not exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI.
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Other: Blood collection, PiB PET/MRI, and cognitive testing
Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status. |
Cognitively impaired
224 of the 1120 enrolled will exhibit subjective impairment as defined by a brief clinical test. These participants will complete an initial blood collection and cognitive testing, and a subset of participants will be asked to return for a larger blood collection, amyloid (PiB) PET imaging, and MRI.
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Other: Blood collection, PiB PET/MRI, and cognitive testing
Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status. |
- Plasma amyloid-beta 42/40 ratio [ Time Frame: Baseline ]
- Plasma amyloid-beta 42/40 ratio [ Time Frame: 6 months ]
- Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status [ Time Frame: 6 months ]
- Coefficient of variation for the initial and confirmatory blood amyloid-beta test results [ Time Frame: 6 months ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
1. At least 60 years of age
Exclusion Criteria:
- Unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment.
- Body weight of <100 pounds
- Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)
- Bleeding disorder
- Pacemaker
- Taking an experimental drug for AD
- Blood donation in the last two months
- Blood transfusion in the last three months
- On hospice

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899844
Contact: Melinda Hamilton | 314-884-8452 | melinda.hamilton@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Melinda Hamilton 314-884-8452 melinda.hamilton@wustl.edu | |
Principal Investigator: Randall Bateman, MD |
Principal Investigator: | Randall Bateman, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03899844 |
Other Study ID Numbers: |
201902081 |
First Posted: | April 2, 2019 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be de-identified to prevent the disclosure of personal identifiers. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | Data will be available immediately following publication with no end date. |
Access Criteria: | Qualified researchers who provide a methodologically sound proposal will be able to access the data to achieve aims in the approved proposal. Proposals should be directed to batemanr@wustl.edu. To gain access, requestors will need to sign a data access agreement. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |