Alzheimer Disease, Cognitive Decline, Dementia, Mild Cognitive Impairment
Conditions
Brief summary
There is an important unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and early dementia. MCI impacts 12-18% of people in the United States over age 60 and is often an initial clinical sign of Alzheimer's disease (AD) (Alzheimer's Association, 2022). The PrecivityAD test is an analytically and clinically validated blood test that aids healthcare providers in the diagnosis of AD in patients with MCI and early-stage dementia. C2N has created a quality improvement (QI) survey to gather insight from clinicians as to the clinical effectiveness of the commercially available PrecivityAD™ test, which identifies whether a patient with signs and symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease.
Detailed description
By gathering feedback from healthcare providers on patient selection, intended use, and anticipated outcomes and continued or revised care plans as a result of the test report, C2N can better understand the impact of the test results on diagnosis and patient management.
Interventions
OTHERPrecivityAD blood test
Clinician Survey post receipt of PrecivityAD blood test result
Sponsors
C2N Diagnostics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Memory specialist actively practicing in the United States. 2. Practice includes individuals with mild cognitive impairment age \> 60 years 3. Average patient volume \> 50 visits per week (all patients seen across practice)
Exclusion criteria
1. Other clinicians with a specialty outside of the field of Memory Specialists 2. Principal Investigator reserves the right to not include a clinician in the survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate patient selection for the blood test through analysis of clinician survey responses. | 2021 - 2023 | retrospective analysis of clinician survey data collected during a single timepoint |
| evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses. | 2021 - 2023 | retrospective analysis of clinician survey data collected during a single timepoint |
Countries
United States
Outcome results
None listed