Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey
Purpose
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-cognitiv e-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-cognitiv e-impairment. Accessed August 16, 2022).
Conditions
- Alzheimer Disease
- Mild Cognitive Impairment
- Dementia
- Cognitive Decline
- Cognitive Impairment
- Memory Impairment
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- ) 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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
More Details
- NCT ID
- NCT06025877
- Status
- Active, not recruiting
- Sponsor
- C2N Diagnostics
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.