NCT06856681

Clinical Utility of Early vs. Late Blood Biomarker Testing for Alzheimer's Disease

A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: C2N Diagnostics · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate whether use of the PrecivityAD2 blood biomarker assay with early result disclosure along with discretionary Precivity-ApoE proteotype testing will shorten the time to Alzheimer's Disease or non-Alzheimer's diagnosis as compared to delayed result disclosure. Participants will be randomized into the early PrecivityAD2 blood biomarker test \& disclosure group (Cohort A) or to the later PrecivityAD2 blood biomarker test \& disclosure group (Cohort B) where blood samples will be collected and tested using the PrecivityAD2 test at Visit 1 (day 0) and Visit 2 (day 90). Participants will attend study visits for one year after their enrollment. An optional sub-study will be offered to collect information through questionnaires at each visit regarding participant's and their care-giver's experiences through the AD diagnostic journey.

Detailed description

Healthcare providers engaged in memory care and Alzheimer's disease (AD) management have shown significant interest in the performance of plasma tests. A collaboration with Veteran's Affairs (VA) and other closed healthcare systems represents an opportunity to examine the clinical validity and utility of blood biomarkers (BBM). The ADELAIDE study is a prospective, randomized, clinical utility, economic impact and real-world study. The BBM test under study is the PrecivityAD2 blood test that uses high-resolution liquid chromatography mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217 ratios. This study will assess and quantify the impact of BBM testing to overall time-to-diagnosis and time to prescription of an appropriate Alzheimer's Disease (AD) or non-AD therapy. Additionally, this study will assess the impact of BBM testing to procedure utilization and overall costs of healthcare and will assess the diagnostic confidence of clinicians that order the test.

Conditions

• Alzheimers Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PrecivityAD2 - Early Testing	Participants in Cohort A will receive PrecivityAD2 testing at Visit 1, with results disclosed shortly after testing.
DIAGNOSTIC_TEST	PrecivityAD2 - Delayed Testing	Participants in Cohort B will receive PrecivityAD2 testing at Visit 2, with results disclosed shortly after testing.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-03-04
• Last updated: 2025-12-16