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

• ClinicalTrials.gov Identifier: NCT03899844
• Recruitment Status: Recruiting
• First Posted: April 2, 2019
• Last Update Posted: February 21, 2021
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment
Alzheimer Disease; Alzheimer Dementia	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 Design

• 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

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Plasma amyloid-beta 42/40 ratio [ Time Frame: Baseline ]
2. Plasma amyloid-beta 42/40 ratio [ Time Frame: 6 months ]
3. Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Coefficient of variation for the initial and confirmatory blood amyloid-beta test results [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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. Pacemaker
6. Taking an experimental drug for AD
7. Blood donation in the last two months
8. Blood transfusion in the last three months
9. On hospice

Contacts and Locations

Contacts

Contact: Melinda Hamilton; 314-884-8452; melinda.hamilton@wustl.edu

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03899844
• Other Study ID Numbers: 201902081
• First Posted: April 2, 2019
• 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

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders