Quality Improvement PrecivityAD Clinician Survey (QUIP I)

Completed

• Conditions: Mild Cognitive Impairment; Cognitive Decline; Dementia; Alzheimer Disease

• Registration Number: NCT05477056
• Lead Sponsor: C2N Diagnostics

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-07-23
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

C2N Diagnostics; 🇺🇸 Saint Louis, Missouri, United States