Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG061900 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.
All participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. Depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for Alzheimer's disease as determined by the participant's medical provider.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical tau PET | Diagnostic Test | Tau PET (flortaucipir) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status | Baseline | |
| Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status | Baseline | |
| Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status | Baseline | |
| Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status | Baseline | |
| Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status | Baseline | |
| Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis | Baseline, 1 year, 2 years, 3 years, 4 years, 5 years | |
| Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis | Baseline, 1 year, 2 years, 3 years, 4 years, 5 years | |
| Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis | Baseline, 1 year, 2 years, 3 years, 4 years, 5 years | |
| Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis | Baseline, 1 year, 2 years, 3 years, 4 years, 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All participants who completed our prior study, the Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD, NCT03899844), will be invited to join SUNBIRD. We will also recruit approximately 1000 new participants from Washington University and Barnes-Jewish Hospital affiliated clinics in the greater St. Louis metropolitan area.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Soke | Contact | 314-747-4857 | sunbirdstudy@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Randall Bateman, MD | Washington University School of Medicine | Principal Investigator |
| David Carr, MD | Washington University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37204806 | Background | 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. | |
| 36087307 | Background | 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. |
Not provided
Not provided
De-identified blood biomarker, clinical cognitive assessment, PET, and demographic data will be made available for sharing in the LONI IDA repository. Genetic data (genome-wide associated studies) will be made available in the dbGaP repository.
Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data is subject to policies followed by dbGaP and LONI IDA repositories.
Given the sensitive nature of the dataset, data will be made available in LONI IDA and dbGaP data repositories, which restrict access to the data to qualified investigators with an approved data use agreement (DUA). Data can be accessed after application and approval through the LONI IDA and dbGaP databases.
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
Not provided
Not provided
Not provided
Plasma, buffy coat, red blood cells
| Clinical amyloid test |
| Diagnostic Test |
Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test |
|
| Research blood collection | Other | Research blood assays for amyloid, tau, and neurodegeneration |
|
| Cognitive assessments | Other | Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA) |
|
| 34542571 | Background | 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. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |