NCT06547099

Study to Understand Novel Biomarkers in Researching Dementia

Blood Amyloid, Tau, and Neurodegeneration Biomarkers and Prediction of Clinical Onset, Cognitive Decline, and Dementia Diagnosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical tau PET	Tau PET (flortaucipir)
DIAGNOSTIC_TEST	Clinical amyloid test	Amyloid PET (florbetapir), CSF amyloid test, or blood amyloid test
OTHER	Research blood collection	Research blood assays for amyloid, tau, and neurodegeneration
OTHER	Cognitive assessments	Clinical Dementia Rating (CDR) or electronic Clinical Dementia Rating (eCDR); Montreal Cognitive Assessment (MoCA)

Timeline

• Start date: 2024-08-14
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-08-09
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States