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There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related\_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related\_conditions/mild-cognitive-impairment. Accessed August 16, 2022).
The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP II) represents a large-scale initiative for the PrecivityAD2 blood test for use by neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients aged 55 years and older with signs or symptoms of MCI or dementia.
C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result |
| |
| Cohort B | Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrecivityAD2(TM) blood test | Other | The PrecivityAD2 blood test measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in planned clinical management (Cohort A and B) | The association of the test result on medical decision making | Day 20 |
| Change in planned clinical management (Cohort B) | Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result | Day 0 vs Day 20 |
| Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B) | Evaluate the intended use criteria | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between the test result and actual clinical management (Cohort B) | Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting | Day 90 |
| Change in planned clinical management compared to conducted clinical management (Cohort B only) |
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Physician Inclusion Criteria:
Physician Exclusion Criteria:
1) Clinicians who practice in New York
Participant Inclusion Criteria:
Participant Exclusion Criteria
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The study population will include up to 40 memory care specialists who will use the PrecivityAD2 blood test and complete the respective surveys. Participating clinicians will be selected based on their ability to meet the acceptance measures from the inclusion and exclusion criteria. Cohort A will include up to 100 test samples collected for the PrecivityAD2 blood test. Cohort B will include up to 300 test samples collected for the PrecivityAD2 blood test.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Monane, MD, MBA, AGSF | Câ‚‚N Diagnostics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Memory and Aging Center | San Francisco | California | 94158 | United States | ||
| Pacific Brain Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39857051 | Result | Monane M, Maraganore DM, Carlile RM, Johnson KG, Merrill DA, Gitelman DR, Sharlin KS, VandeVrede LA, George KK, Wang J, West T, Jacobs L, Verghese PB, Braunstein JB. Clinical Utility of an Alzheimer's Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study. Diagnostics (Basel). 2025 Jan 13;15(2):167. doi: 10.3390/diagnostics15020167. |
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|
|
The evaluation of planned versus conducted change in management as a result of receiving the test result |
| Day 20 vs Day 90 |
| Change in probability of AD (Cohort A and B) | Evaluate the probability of an AD Dx pre and post receipt of the test result | Day 0 vs Day 20 |
| Change in anti-AD medication use (Cohort A and B) | Evaluate anti-AD medication use pre- and post-receipt of the test result | Day 0 vs Day 20 |
| Change in diagnosis (Cohort B) | Evaluate any changes in diagnoses as a result of receiving the AD test result | Day 0 vs Day 90 |
| Relationship between the test result and planned testing (Cohort B) | Evaluate the association between subsequent test ordering pre and post testing | Day 0 vs Day 20 vs Day 90 |
| Correlations between the net promoter score and ease of use by APS2 result (Cohort B) | Focus group questions around net promoter score and ease of use, strengths, and limitations of testing | Day 90 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Advocate Memory Center | Park Ridge | Illinois | 60068 | United States |
| Josephson Wallack Munshower Neurology, P.C. | Indianapolis | Indiana | 46256 | United States |
| Tulane Doctors Neurosurgery Clinic | New Orleans | Louisiana | 70006 | United States |
| Memorial Healthcare Institute for Neuroscience | Owosso | Michigan | 48867 | United States |
| Sharlin Health and Neurology | Ozark | Missouri | 65721 | United States |
| C2N Diagnostics | St Louis | Missouri | 63110 | United States |
| Palmetto Primary Care Physicians | Summerville | South Carolina | 29486 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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