Clinical trial NCT06025877: Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey
Official title: Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Cognitive Decline
Cognitive Impairment
Memory Impairment
Lead sponsor: C2N Diagnostics
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 400
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Physician Inclusion Criteria:

1. Memory care specialists actively practicing in the United States
2. Practice serves individuals with MCI or dementia age \> 55 years
3. Average patient volume \> 25 visits per week (all patients seen across practice)
4. Memory care specialist with access to an online electronic survey

Physician Exclusion Criteria:

1) Clinicians who practice in New York

Participant Inclusion Criteria:

1. Individual with MCI or dementia
2. Age \>= 55 years

Participant Exclusion Criteria

1. Individual requiring test related blood draw within the state of New York
2. Participation does not seem to be in the best interest of the individual, per the ordering clinician

Primary outcomes:
measure: Change in planned clinical management (Cohort A and B)
timeFrame: Day 20
measure: Change in planned clinical management (Cohort B)
timeFrame: Day 0 vs Day 20
measure: Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)
timeFrame: Day 90
Secondary outcomes:
measure: Relationship between the test result and actual clinical management (Cohort B)
timeFrame: Day 90
measure: Change in planned clinical management compared to conducted clinical management (Cohort B only)
timeFrame: Day 20 vs Day 90
measure: Change in probability of AD (Cohort A and B)
timeFrame: Day 0 vs Day 20
measure: Change in anti-AD medication use (Cohort A and B)
timeFrame: Day 0 vs Day 20
measure: Change in diagnosis (Cohort B)
timeFrame: Day 0 vs Day 90
measure: Relationship between the test result and planned testing (Cohort B)
timeFrame: Day 0 vs Day 20 vs Day 90
measure: Correlations between the net promoter score and ease of use by APS2 result (Cohort B)
timeFrame: Day 90
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Memory and Aging Center
state: California
city: Santa Monica
country: United States
facility: Pacific Brain Health Center
state: California
city: Park Ridge
country: United States
facility: Advocate Memory Center
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, P.C.
state: Indiana
city: New Orleans
country: United States
facility: Tulane Doctors Neurosurgery Clinic
state: Louisiana
city: Owosso
country: United States
facility: Memorial Healthcare Institute for Neuroscience
state: Michigan
city: Ozark
country: United States
facility: Sharlin Health and Neurology
state: Missouri
city: St. Louis
country: United States
facility: C2N Diagnostics
state: Missouri
city: Summerville
country: United States
facility: Palmetto Primary Care Physicians
state: South Carolina
Study officials:
affiliation: C₂N Diagnostics, LLC
name: Mark Monane, MD, MBA, AGSF
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.