Study to Understand Novel Biomarkers in Researching Dementia (SUNBIRD)

The Washington University

Status: Enrolling

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Treatments: Diagnostic Test: Clinical amyloid test; Diagnostic Test: Clinical tau PET; Other: Research blood collection; Other: Cognitive assessments

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06547099

R01AG061900 (U.S. NIH Grant/Contract)

202405156

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,800 participants in 2 patient groups

Cognitively normal

Description:

Participants without symptoms of cognitive impairment will be followed up annually for potential cognitive changes, and will complete additional blood collections every two years.

Treatment:

Other: Cognitive assessments

Other: Research blood collection

Cognitively impaired

Description:

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.

Treatment:

Other: Cognitive assessments

Other: Research blood collection

Diagnostic Test: Clinical amyloid test

Diagnostic Test: Clinical tau PET