Study to Understand Novel Biomarkers in Researching Dementia
NCT ID: NCT06547099
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1800 participants
OBSERVATIONAL
2024-08-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cognitively normal
Participants without symptoms of cognitive impairment will be followed up annually for potential cognitive changes, and will complete additional blood collections every two years.
Research blood collection
Research blood assays for amyloid, tau, and neurodegeneration
Cognitive assessments
Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
Cognitively impaired
For participants with symptoms of cognitive impairment, their medical providers will review the results of the research cognitive assessments and determine whether further testing (a clinical tau PET scan and choice of an amyloid PET, cerebrospinal fluid, or blood clinical test for amyloid plaques) is needed. Symptomatic participants will be followed up annually for research blood collections and cognitive assessments.
Clinical tau PET
Tau PET (flortaucipir)
Clinical amyloid test
Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
Research blood collection
Research blood assays for amyloid, tau, and neurodegeneration
Cognitive assessments
Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
Interventions
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Clinical tau PET
Tau PET (flortaucipir)
Clinical amyloid test
Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
Research blood collection
Research blood assays for amyloid, tau, and neurodegeneration
Cognitive assessments
Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
Eligibility Criteria
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Inclusion Criteria
* 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and/or provider
* All SEABIRD participants will be invited to participate regardless of their cognitive status
Exclusion Criteria
* Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection
* Taking a disease-modifying drug for AD at time of enrollment
* Blood transfusion in the last three months
* Unwilling or unable to participate in all study activities
60 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Randall Bateman, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
David Carr, MD
Role: STUDY_DIRECTOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Li M, Li Y, Schindler SE, Yen D, Sutcliffe S, Babulal GM, Benzinger TLS, Lenze EJ, Bateman RJ. Design and feasibility of an Alzheimer's disease blood test study in a diverse community-based population. Alzheimers Dement. 2023 Dec;19(12):5387-5398. doi: 10.1002/alz.13125. Epub 2023 May 19.
Janelidze S, Bali D, Ashton NJ, Barthelemy NR, Vanbrabant J, Stoops E, Vanmechelen E, He Y, Dolado AO, Triana-Baltzer G, Pontecorvo MJ, Zetterberg H, Kolb H, Vandijck M, Blennow K, Bateman RJ, Hansson O. Head-to-head comparison of 10 plasma phospho-tau assays in prodromal Alzheimer's disease. Brain. 2023 Apr 19;146(4):1592-1601. doi: 10.1093/brain/awac333.
Janelidze S, Teunissen CE, Zetterberg H, Allue JA, Sarasa L, Eichenlaub U, Bittner T, Ovod V, Verberk IMW, Toba K, Nakamura A, Bateman RJ, Blennow K, Hansson O. Head-to-Head Comparison of 8 Plasma Amyloid-beta 42/40 Assays in Alzheimer Disease. JAMA Neurol. 2021 Nov 1;78(11):1375-1382. doi: 10.1001/jamaneurol.2021.3180.
Other Identifiers
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202405156
Identifier Type: -
Identifier Source: org_study_id
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