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CompletedNCT05477056QUIP IUpdated Feb 20, 2025

Quality Improvement PrecivityAD Clinician Survey (QUIP I)

An observational study in Alzheimer Disease, Mild Cognitive Impairment and Dementia, sponsored by C2N Diagnostics. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by C2N Diagnostics · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
366
Ages
60 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Dementia
  • Cognitive Decline
03

In context

Alzheimer Disease

3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 366 is above the median of 200 across 780 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

C2N Diagnostics is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
366 participants (actual)
Patient registry
No

Interventions

  • OtherPrecivityAD blood test

    Clinician Survey post receipt of PrecivityAD blood test result

    Also known as: AD

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What researchers measure

Primary outcomes

  1. evaluate patient selection for the blood test through analysis of clinician survey responses.

    retrospective analysis of clinician survey data collected during a single timepoint

    Time frame: 2021 - 2023

  2. 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

    Time frame: 2021 - 2023

07

Study locations

1 site
  • C2N Diagnostics
    St Louis, Missouri 63110, United States
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References and documents

Publications

  • 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. PubMed 37550958 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Oct 2022, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2022
First posted
Jul 28, 2022
StartActual
Mar 1, 2021
Primary completionActual
Oct 6, 2022
CompletionActual
Oct 6, 2022
Last update
Feb 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05477056
Lead sponsor
C2N Diagnostics
Responsible party
Sponsor
First posted
Jul 28, 2022
Start date
Mar 1, 2021
Primary completion
Oct 6, 2022
Completion
Oct 6, 2022
Last update
Feb 20, 2025

Study contacts

Tim West, Ph.D
principal investigator · C2N

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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