Clinical trial NCT05477056: Quality Improvement PrecivityAD Clinician Survey (QUIP I)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Cognitive Decline
Lead sponsor: C2N Diagnostics
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 366
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: evaluate patient selection for the blood test through analysis of clinician survey responses.
timeFrame: 2021 - 2023
measure: evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses.
timeFrame: 2021 - 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: C2N Diagnostics
state: Missouri
Study officials:
affiliation: C2N
name: Tim West, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.