Quality Improvement Survey I.0: A Retrospective Data Analysis of Clinician Survey Responses Following the Utilization of the PrecivityADTM Blood Test for the Detection of Alzheimer's Disease Pathology (QUIP I)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- C2N Diagnostics
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- evaluate patient selection for the blood test through analysis of clinician survey responses.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Memory specialist actively practicing in the United States.
- •Practice includes individuals with mild cognitive impairment age \> 60 years
- •Average patient volume \> 50 visits per week (all patients seen across practice)
Exclusion Criteria
- •Other clinicians with a specialty outside of the field of Memory Specialists
- •Principal Investigator reserves the right to not include a clinician in the survey
Outcomes
Primary Outcomes
evaluate patient selection for the blood test through analysis of clinician survey responses.
Time Frame: 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.
Time Frame: 2021 - 2023
retrospective analysis of clinician survey data collected during a single timepoint