Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD)

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Alzheimer Dementia
• Intervention / Treatment: Other: Blood collection, PiB PET/MRI, and cognitive testing

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.

• Study Type: Observational
• Enrollment (Actual): 1122

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.	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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma amyloid-beta 42/40 ratio	Baseline
Plasma amyloid-beta 42/40 ratio	6 months
Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Randall Bateman, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 201902081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be available immediately following publication with no end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No