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Study to Evaluate Amyloid in Blood and Imaging Related to Dementia

Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03899844
Acronym
SEABIRD
Enrollment
1122
Registered
2019-04-02
Start date
2019-04-09
Completion date
2024-01-31
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Dementia, Alzheimer Disease

Brief summary

The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET imaging, and an MRI.

Detailed description

Alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. Amyloid beta builds up in the brain and forms plaques in people with Alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. A blood test may be able to quickly and inexpensively screen people for Alzheimer's disease clinical trials and eventually diagnose Alzheimer's disease in the clinic.

Interventions

OTHERBlood 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum

Inclusion criteria

1\. At least 60 years of age

Exclusion criteria

1. 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. 2. Body weight of \<100 pounds 3. Active infectious disease (e.g., HIV, hepatitis B, hepatitis C) 4. Bleeding disorder 5. Taking an experimental drug for AD 6. Blood donation in the last two months 7. Blood transfusion in the last three months 8. On hospice

Design outcomes

Primary

MeasureTime frame
Plasma amyloid-beta 42/40 ratioBaseline
Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status6 months

Secondary

MeasureTime frame
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026