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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Participants in Cohort A will receive PrecivityAD2 testing at Visit 1, with results disclosed shortly after testing.
Participants in Cohort B will receive PrecivityAD2 testing at Visit 2, with results disclosed shortly after testing.
Time to achieve >=90% Diagnostic Confidence for AD or Non-AD
Number of days from enrollment to achieving a diagnostic confidence score of \>=90% for AD or non-AD diagnosis (based on physician survey).
Time frame: From enrollment until diagnosis, with primary assessment at Visit 2 (Day 90) and Visit 3 (Day 180).
Proportion of Patients with AD of Non-AD Diagnosis
Proportion of patients with a confirmed AD or non-AD diagnosis with a diagnostic confidence score of \>=90%.
Time frame: Assessed at Visit 2 (Day 90) and Visit 3 (Day 180)
Time to Initiation or Modification of AD or Non-AD Therapy
Number of days from enrollment to the prescription, initiation, or modification of an AD or non-AD therapy. Data will be sourced from medical records and recorded in eCRF.
Time frame: Measured from enrollment through Visit 4 (Day 365).
Proportion of patients on AD or non-AD prescription
Proportion of patients on AD or non-AD prescription (e.g., DMT, treatments for DLB/PDD or VaD, cholinesterase inhibitors, other) at Visit 3 (150-210).
Time frame: Assessed at Visit 3 (150-210)
Number and Type of Diagnostic Tests Ordered
Total number and type of additional diagnostic tests ordered (e.g., amyloid PET, MRI, CSF biomarkers) from Visit 2 (Day 90) through the date of AD or non-AD diagnosis with physician confidence \>=90%. Data will be collected via physician-reported case forms.
Time frame: Evaluated cumulatively at Visit 2 (Day 90), Visit 3 (Day 180), and Visit 4 (Day 365)
Change in Physician Diagnostic Confidence
Comparison of physician reported confidence of AD or non-AD diagnosis (0-100%) before and after receiving PrecivityAD2 results. Confidence scores will be collected by physician survey.
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Time frame: Collected at Enrollment/Baseline (Day 0), Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365)