Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis
Overview
- Phase
- Not Applicable
- Intervention
- Research blood collection
- Conditions
- Alzheimer Disease
- Sponsor
- Washington University School of Medicine
- Enrollment
- 1800
- Locations
- 1
- Primary Endpoint
- Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Research blood collection
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.
Intervention: Cognitive assessments
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.
Intervention: Clinical tau PET
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.
Intervention: Clinical amyloid test
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.
Intervention: Research blood collection
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.
Intervention: Cognitive assessments
Outcomes
Primary Outcomes
Area under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis
Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status
Time Frame: Baseline
Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status
Time Frame: Baseline
Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis
Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis
Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status
Time Frame: Baseline
Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status
Time Frame: Baseline
Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status
Time Frame: Baseline
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis
Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years