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

NCT06856681 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

  • Alzheimers Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Vice President, Neurology · C2N Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-12-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856681 on ClinicalTrials.gov