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sponsor decision to cancel project before enrollment.
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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Testing Group (Cohort A) | Experimental | Participants in this group will have blood drawn from the PrecivityAD2 test at Visit 1 (Day 0). Physicians will use these results in clinical decision-making from that point forward. |
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| Delayed Testing Group (Cohort B) | Experimental | Participants in this group will have blood drawn for the PrecivityAD2 test at Visit 2 (Day 90). Until then, standard clinical decision-making will process without access to PrecivityAD2 results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrecivityAD2 - Early Testing | Diagnostic Test | Participants in Cohort A will receive PrecivityAD2 testing at Visit 1, with results disclosed shortly after testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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%. | Assessed at Visit 2 (Day 90) and Visit 3 (Day 180) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured from enrollment through Visit 4 (Day 365). |
| Proportion of patients on AD or non-AD prescription |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Experience with Diagnostic Process | Patient-reported experience with the diagnostic journey, including perception of the clarity and utility of PrecivityAD2 results. Assessed using patient surveys. | Collected at Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365) |
| Caregiver-Reported Perception of Disease Burden |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Vice President, Neurology | C2N Diagnostics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38491912 | Background | Meyer MR, Kirmess KM, Eastwood S, Wente-Roth TL, Irvin F, Holubasch MS, Venkatesh V, Fogelman I, Monane M, Hanna L, Rabinovici GD, Siegel BA, Whitmer RA, Apgar C, Bateman RJ, Holtzman DM, Irizarry M, Verbel D, Sachdev P, Ito S, Contois J, Yarasheski KE, Braunstein JB, Verghese PB, West T. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Abeta42/40 ratio to identify presence of brain amyloid. Alzheimers Dement. 2024 May;20(5):3179-3192. doi: 10.1002/alz.13764. Epub 2024 Mar 16. | |
| 39068545 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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This study uses a parallel assignment interventional model in which participants are randomized into one of two groups to evaluate the impact of the timing of PrecivityAD2 test on physician diagnostic confidence and clinical decision-making. Participants in the early testing group receive their PrecivityAD2 test at Visit 1, while those in the delayed testing group receive their results at Visit 3 (Day 90). Both groups proceed independently through the study, and assessments occur at standardized time points to measure changes in diagnostic confidence, treatment decision, and diagnostic test utilization.
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| PrecivityAD2 - Delayed Testing | Diagnostic Test | Participants in Cohort B will receive PrecivityAD2 testing at Visit 2, with results disclosed shortly after testing. |
|
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). |
| 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. | 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. | Collected at Enrollment/Baseline (Day 0), Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365) |
Caregiver-reported assessment of disease burden, changes in the patient's condition, and perceived impact on daily life. Collected through structured caregiver surveys. |
| Collected at Visit 2 (Day 90), Visit 3 (Day 180) and Visit 4 (Day 365) |
| Healthcare Utilization and Costs | Total healthcare costs associated with diagnostic evaluations, physician visits, and treatments. Healthcare utilization and cost data will be collected from medical records and analyzed retrospectively after Visit 4 (Day 365). | Enrollment through Visit 4 (Day 365) |
| Background |
| Palmqvist S, Tideman P, Mattsson-Carlgren N, Schindler SE, Smith R, Ossenkoppele R, Calling S, West T, Monane M, Verghese PB, Braunstein JB, Blennow K, Janelidze S, Stomrud E, Salvado G, Hansson O. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care. JAMA. 2024 Oct 15;332(15):1245-1257. doi: 10.1001/jama.2024.13855. |
| 38866966 | Background | Schindler SE, Galasko D, Pereira AC, Rabinovici GD, Salloway S, Suarez-Calvet M, Khachaturian AS, Mielke MM, Udeh-Momoh C, Weiss J, Batrla R, Bozeat S, Dwyer JR, Holzapfel D, Jones DR, Murray JF, Partrick KA, Scholler E, Vradenburg G, Young D, Algeciras-Schimnich A, Aubrecht J, Braunstein JB, Hendrix J, Hu YH, Mattke S, Monane M, Reilly D, Somers E, Teunissen CE, Shobin E, Vanderstichele H, Weiner MW, Wilson D, Hansson O. Acceptable performance of blood biomarker tests of amyloid pathology - recommendations from the Global CEO Initiative on Alzheimer's Disease. Nat Rev Neurol. 2024 Jul;20(7):426-439. doi: 10.1038/s41582-024-00977-5. Epub 2024 Jun 12. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |