Quality Improvement PrecivityAD Clinician Survey (QUIP I)

• Sponsor: C2N Diagnostics (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05477056
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 18.1
• Patients Per Site Per Month: 16.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Mild Cognitive Impairment; Dementia; Cognitive Decline	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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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)
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Sep 2, 2022
• Anticipated Study Completion Date: Sep 2, 2022

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Neurologist 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 Neurology

2. Principal Investigator reserves the right to not include a clinician in the survey

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C2N Diagnostics	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• C2N Diagnostics

Investigators

• Principal Investigator: Tim West, Ph.D, C2N

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C2N Diagnostics
• ClinicalTrials.gov Identifier: NCT05477056
• Other Study ID Numbers: C2N001
• First Posted: Jul 28, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Aug 1, 2022