跳至主要内容
临床试验/NCT05477056
NCT05477056已完成不适用

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)

C2N Diagnostics1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
366
试验地点
1
主要终点
evaluate patient selection for the blood test through analysis of clinician survey responses.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: 2021 - 2023

retrospective analysis of clinician survey data collected during a single timepoint

evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses.

时间窗: 2021 - 2023

retrospective analysis of clinician survey data collected during a single timepoint

次要结局

未报告次要终点

研究者

发起方
C2N Diagnostics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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