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Clinical Trials/NCT06025877
NCT06025877
Active, not recruiting
Not Applicable

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

C2N Diagnostics9 sites in 1 country400 target enrollmentNovember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
C2N Diagnostics
Enrollment
400
Locations
9
Primary Endpoint
Change in planned clinical management (Cohort A and B)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
April 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
C2N Diagnostics
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Clinicians who practice in New York
  • Participant Inclusion Criteria:
  • Individual with MCI or dementia
  • Age \>= 55 years
  • Participant Exclusion Criteria
  • Individual requiring test related blood draw within the state of New York
  • Participation does not seem to be in the best interest of the individual, per the ordering clinician

Outcomes

Primary Outcomes

Change in planned clinical management (Cohort A and B)

Time Frame: Day 20

The association of the test result on medical decision making

Change in planned clinical management (Cohort B)

Time Frame: Day 0 vs Day 20

Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result

Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)

Time Frame: Day 90

Evaluate the intended use criteria

Secondary Outcomes

  • Relationship between the test result and actual clinical management (Cohort B)(Day 90)
  • Change in planned clinical management compared to conducted clinical management (Cohort B only)(Day 20 vs Day 90)
  • Change in probability of AD (Cohort A and B)(Day 0 vs Day 20)
  • Change in anti-AD medication use (Cohort A and B)(Day 0 vs Day 20)
  • Relationship between the test result and planned testing (Cohort B)(Day 0 vs Day 20 vs Day 90)
  • Change in diagnosis (Cohort B)(Day 0 vs Day 90)
  • Correlations between the net promoter score and ease of use by APS2 result (Cohort B)(Day 90)

Study Sites (9)

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