Quality Improvement PrecivityAD Clinician Survey (QUIP I)

NCT ID: NCT05477056

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-10-06

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Mild Cognitive Impairment Dementia Cognitive Decline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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PrecivityAD blood test

Clinician Survey post receipt of PrecivityAD blood test result

Intervention Type OTHER

Other Intervention Names

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AD

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C2N Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim West, Ph.D

Role: PRINCIPAL_INVESTIGATOR

C2N

Locations

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C2N Diagnostics

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Monane M, Johnson KG, Snider BJ, Turner RS, Drake JD, Maraganore DM, Bicksel JL, Jacobs DH, Ortega JL, Henderson J, Jiang Y, Huang S, Coppinger J, Fogelman I, West T, Braunstein JB. A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment. Ann Clin Transl Neurol. 2023 Oct;10(10):1738-1748. doi: 10.1002/acn3.51863. Epub 2023 Aug 7.

Reference Type RESULT
PMID: 37550958 (View on PubMed)

Other Identifiers

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C2N001

Identifier Type: -

Identifier Source: org_study_id

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