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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899844
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
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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
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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
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
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Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Sullivan 314-747-4857 m.sullivan@wustl.edu
Contact: Tinishia Greene, RN 314-273-7935 greene.t.d@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Melissa Sullivan    314-747-4857    m.sullivan@wustl.edu   
Contact: Tinishia Greene, RN    314-273-7935    greene.t.d@wustl.edu   
Principal Investigator: Randall Bateman, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Randall Bateman, MD Washington University School of Medicine
More Information
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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: January 30, 2020
Last Verified: January 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders