Alzheimer Disease, Mild Cognitive Impairment, Dementia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTClinical tau PET
Tau PET (flortaucipir)
DIAGNOSTIC_TESTClinical amyloid test
Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
Research blood assays for amyloid, tau, and neurodegeneration
Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)
Sponsors
Washington University School of Medicine
National Institute on Aging (NIA)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 60 years of age * 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
* Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment * 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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
CONTACTLisa Soke
PRINCIPAL_INVESTIGATORRandall Bateman, MD
Washington University School of Medicine
STUDY_DIRECTORDavid Carr, MD
Washington University School of Medicine
Outcome results
None listed