Quality Improvement PrecivityAD Clinician Survey (QUIP I)

NCT05477056 | Completed

• 1 other identifier: C2N001
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia; Cognitive Decline

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

PrecivityAD blood test OTHER

Clinician Survey post receipt of PrecivityAD blood test result

Also known as: AD

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Memory specialist actively practicing in the United States.
• Practice includes individuals with mild cognitive impairment age \> 60 years
• Average patient volume \> 50 visits per week (all patients seen across practice)

You may not qualify if:

• Other clinicians with a specialty outside of the field of Memory Specialists
• Principal Investigator reserves the right to not include a clinician in the survey

Sponsors & Collaborators

• C2N Diagnostics: lead

Study Sites (1)

C2N Diagnostics

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 37550958 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Tim West, Ph.D

  C2N

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 28, 2022
• Study Start: March 1, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)