Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT05477056
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2022-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality Improvement PrecivityAD Clinician Survey (QUIP I)
Sponsor:
C2N Diagnostics
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUIP I
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: