Quality Improvement PrecivityAD Clinician Survey (QUIP I)

Alzheimer Disease Clinical Trial

— QUIP I  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05477056
• Other study ID #: C2N001
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: August 2023
• Source: C2N Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Other:
• PrecivityAD blood test
Clinician Survey post receipt of PrecivityAD blood test result

Locations

Country	Name	City	State
United States	C2N Diagnostics	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
C2N Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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