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Study to Understand Novel Biomarkers in Researching Dementia

Study acronym: SUNBIRD
StatusRecruiting
PhaseNot specified
Started2024-08-14
View on ClinicalTrials.gov ↗
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.

Amendment history 1 change detected by DataLookout

2026-09-12
critical
Primary endpoint(s) modified
WasArea under the curve (AUC) of plasma %p-tau205 in predicting clinical diagnosis, Area under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status, Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis, Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status, Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis, Area under the curve (AUC) of plasma neurofilament light in predicting clinical diagnosis, Area under the curve (AUC) of plasma neurofilament light in predicting tau PET status, Area under the curve (AUC) of plasma p-tau205 in predicting tau PET status, Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status
NowArea under the curve (AUC) of plasma %p-tau217 in predicting amyloid PET status, Area under the curve (AUC) of plasma %p-tau217 in predicting clinical diagnosis, Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting amyloid PET status, Area under the curve (AUC) of plasma amyloid-beta 42/40 in predicting clinical diagnosis, Area under the curve (AUC) of plasma p-tau217 in predicting tau PET status
Trial Details
NCT Number NCT06547099
Lead Sponsor Washington University School of Medicine
Collaborators: National Institute on Aging (NIA)
Conditions Alzheimer Disease, Mild Cognitive Impairment, Dementia
Enrollment 1,800 participants
Start Date 2024-08-14
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-11