Study to Understand Novel Biomarkers in Researching Dementia

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia
• Interventions: Other: Research blood collection; Diagnostic Test: Clinical tau PET; Diagnostic Test: Clinical amyloid test; Other: Cognitive assessments

• Registration Number: NCT06547099
• Lead Sponsor: Washington University School of Medicine

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...

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 p...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Study Start: 2024-08-14
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1800

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cognitively impaired	Cognitive assessments	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.
Cognitively normal	Research blood collection	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 normal	Cognitive assessments	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	Clinical tau PET	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.
Cognitively impaired	Clinical amyloid test	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.
Cognitively impaired	Research blood collection	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.

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid 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 neurofilament light 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 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 amyloid-beta 42/40 in predicting clinical diagnosis	Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States