Alzheimer Disease, Cognitive Decline, Cognitive Impairment, Dementia, Memory Impairment, Mild Cognitive Impairment
Conditions
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.
Interventions
OTHERPrecivityAD2(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.
Sponsors
C2N Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in planned clinical management (Cohort A and B) | Day 20 | The association of the test result on medical decision making |
| Change in planned clinical management (Cohort B) | 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) | Day 90 | Evaluate the intended use criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anti-AD medication use (Cohort A and B) | Day 0 vs Day 20 | Evaluate anti-AD medication use pre- and post-receipt of the test result |
| Change in diagnosis (Cohort B) | Day 0 vs Day 90 | Evaluate any changes in diagnoses as a result of receiving the AD test result |
| Relationship between the test result and actual clinical management (Cohort B) | Day 90 | 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 |
| Correlations between the net promoter score and ease of use by APS2 result (Cohort B) | Day 90 | Focus group questions around net promoter score and ease of use, strengths, and limitations of testing |
| Relationship between the test result and planned testing (Cohort B) | Day 0 vs Day 20 vs Day 90 | Evaluate the association between subsequent test ordering pre and post testing |
| Change in planned clinical management compared to conducted clinical management (Cohort B only) | Day 20 vs Day 90 | The evaluation of planned versus conducted change in management as a result of receiving the test result |
| Change in probability of AD (Cohort A and B) | Day 0 vs Day 20 | Evaluate the probability of an AD Dx pre and post receipt of the test result |
Countries
United States
Outcome results
None listed