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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 : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date March 22, 2019
First Posted Date April 2, 2019
Last Update Posted Date July 2, 2020
Actual Study Start Date April 9, 2019
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2020)
  • 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 ]
Original Primary Outcome Measures
 (submitted: April 1, 2019)
  • Plasma amyloid-beta 42/40 ratio [ Time Frame: Baseline ]
  • Plasma amyloid-beta 42/40 ratio [ Time Frame: 3 months ]
  • Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures
 (submitted: January 28, 2020)
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results [ Time Frame: 6 months ]
Original Secondary Outcome Measures
 (submitted: April 1, 2019)
Coefficient of variation for the initial and confirmatory blood amyloid-beta test results [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate Amyloid in Blood and Imaging Related to Dementia
Official Title Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.
Condition
  • Alzheimer Disease
  • Alzheimer Dementia
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Blood collection, PiB PET/MRI, and cognitive testing
  • 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.
    Intervention: Other: Blood collection, PiB PET/MRI, and cognitive testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 1, 2019)
1120
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Tinishia Greene, RN 314-884-8452 greene.t.d@wustl.edu
Contact: Melinda Hamilton 314-884-8452 melinda.hamilton@wustl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03899844
Other Study ID Numbers 201902081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: 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.
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Randall Bateman, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2020