Quality Improvement PrecivityAD Clinician Survey (QUIP I) (QUIP I)

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)

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline
• Intervention / Treatment: Other: PrecivityAD blood test

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 Type: Observational
• Enrollment (Actual): 366

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • C2N Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Memory Specialists actively practicing in the United States were asked to complete the QI 1.0 survey with expertise in caring for patients with mild cognitive impairment and knowledge of Alzheimer's Disease in terms of expertise and volume of patients served. This may include nurse practitioners or physician assistants who work in the field of Memory Disorders.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate patient selection for the blood test through analysis of clinician survey responses.	retrospective analysis of clinician survey data collected during a single timepoint	2021 - 2023
evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses.	retrospective analysis of clinician survey data collected during a single timepoint	2021 - 2023

Collaborators and Investigators

• Sponsor: C2N Diagnostics
• Investigators: Principal Investigator: Tim West, Ph.D, C2N

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: July 23, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: C2N001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No