Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey (QUIP II)

Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)

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).

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline; Memory Impairment
• Intervention / Treatment: Other: PrecivityAD2(TM) blood test

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Leslie M Jacobs, CCRP, PMP; Phone Number: 314-464-0002; Email: ljacobs@c2n.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Memory and Aging Center
      • Contact: Lawren VandeVrede, MD; Phone Number: 415-353-4557; Email: Lawren.vandevrede@ucsf.edu
      • Principal Investigator: Lawren VandeVre, MD
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Pacific Brain Health Center
      • Contact: Phone Number: 503-582-7641; Email: PacificBrainHealthCenter@providence.org
      • Principal Investigator: David Merrill, MD
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Memory Center
      • Principal Investigator: Darren Gitelman, MD
      • Contact: Darren Gitelman, MD; Phone Number: 847-720-6464; Email: darren.gitelman@aah.org
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Recruiting
      • Josephson Wallack Munshower Neurology, P.C.
      • Principal Investigator: Kristi George, MD
      • Contact: Tajuana Booker, CRC; Phone Number: 317-537-6061; Email: Tbooker@jwmneuro.com
  • Louisiana
    • New Orleans, Louisiana, United States, 70006
      • Recruiting
      • Tulane Doctors Neurosurgery Clinic
      • Contact: Sereen Askar; Phone Number: 504-503-7001; Email: saskar@tulane.edu
      • Principal Investigator: Demetrius Maraganore, MD
  • Missouri
    • Ozark, Missouri, United States, 65721
      • Recruiting
      • Sharlin Health and Neurology
      • Contact: Shawna Tindall; Phone Number: 1005 417-485-4330; Email: shawna@sharlinfxmed.com
      • Principal Investigator: Ken Sharlin, MD
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • C2N Diagnostics
      • Contact: Leslie M Jacobs; Phone Number: 314-464-0002; Email: ljacobs@c2n.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result	Other: PrecivityAD2(TM) blood 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.; Other Names: AD2
Cohort B; Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result	Other: PrecivityAD2(TM) blood 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.; Other Names: AD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: C2N Diagnostics
• Investigators: Principal Investigator: Mark Monane, MD, MBA, AGSF, C₂N Diagnostics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: C2N002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No