Clinical value of Alzheimer's disease biomarker testing

IF 4.9 Q1 CLINICAL NEUROLOGY

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Pub Date : 2024-04-08 DOI:10.1002/trc2.12464

Khushbu J. Patel, David Yang, John R. Best, Colleen Chambers, Philip E. Lee, Alexandre Henri-Bhargava, Clark R. Funnell, Dean J. Foti, Jacqueline A. Pettersen, Howard H. Feldman, Haakon B. Nygaard, Ging-Yuek R. Hsiung, Mari L. DeMarco

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Abstract

INTRODUCTION

In the Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia (IMPACT-AD BC) study, we aimed to understand how Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarker testing—used in medical care—impacted medical decision-making (medical utility), personal decision-making (personal utility), and health system economics.

METHODS

The study was designed as an observational, longitudinal cohort study. A total of 149 patients were enrolled between February 2019 and July 2021. Patients referred to memory clinics were approached to participate if their dementia specialist ordered AD CSF biomarker testing as part of their routine medical care, and the clinical scenario met the appropriate use criteria for lumbar puncture and AD CSF biomarker testing. For the medical utility pillar, detailed clinical management plans were collected via physician questionnaires pre- and post-biomarker disclosure.

RESULTS

Patients with completed management questionnaires (n = 142) had a median age of 64 (interquartile range: 59–69) years, 48% were female, and 60% had CSF biomarker profiles on the AD continuum. Clinical management changed in 89.4% of cases. AD biomarker testing was associated with decreased need for other diagnostic procedures, including brain imaging (–52.0%) and detailed neuropsychological assessments (–63.2%), increased referrals and counseling (57.0%), and guided AD-related drug prescriptions (+88.4% and –50.0% in biomarker-positive and -negative cases, respectively).

DISCUSSION

AD biomarker testing was associated with significant and positive changes in clinical management, including decreased health care resource use, therapy optimization, and increased patient and family member counseling. While certain changes in management were linked to the AD biomarker profile (e.g., referral to clinical trials), the majority of changes were independent of baseline clinical presentation and level of cognitive impairment, demonstrating a broad value for AD biomarker testing in individuals meeting the appropriate use criteria for testing.

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阿尔茨海默病生物标志物检测的临床价值

引言在不列颠哥伦比亚省阿尔茨海默病诊断影响调查（IMPACT-AD BC）研究中，我们旨在了解医疗护理中使用的阿尔茨海默病（AD）脑脊液（CSF）生物标志物检测如何影响医疗决策（医疗效用）、个人决策（个人效用）和医疗系统经济。方法该研究是一项观察性纵向队列研究。共有 149 名患者在 2019 年 2 月至 2021 年 7 月期间入组。如果转诊到记忆门诊的患者的痴呆症专科医生要求进行 AD CSF 生物标志物检测，并将其作为常规医疗护理的一部分，且临床情景符合腰椎穿刺和 AD CSF 生物标志物检测的适当使用标准，则该患者将被邀请参与研究。在医疗效用方面，通过生物标记物披露前后的医生问卷调查收集了详细的临床管理计划。结果完成管理问卷调查的患者（n = 142）的中位年龄为 64 岁（四分位间距：59-69），48% 为女性，60% 的患者的脑脊液生物标记物特征符合 AD 连续体。89.4%的病例改变了临床管理。AD生物标志物检测与其他诊断程序需求的减少有关，包括脑成像（-52.0%）和详细的神经心理学评估（-63.2%）、转诊和咨询的增加（57.0%）以及AD相关药物处方的指导（在生物标志物阳性和阴性病例中分别为+88.4%和-50.0%）。讨论 AD 生物标志物检测与临床管理方面的重大积极变化有关，包括减少医疗资源的使用、优化治疗以及增加患者和家属咨询。虽然管理方面的某些变化与注意力缺失症生物标志物特征有关（如转诊到临床试验），但大多数变化与基线临床表现和认知障碍程度无关，这表明注意力缺失症生物标志物检测对符合检测适当使用标准的个体具有广泛价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Medicine-Psychiatry and Mental Health

CiteScore

10.10

自引率

2.10%

发文量

134

审稿时长

10 weeks

期刊介绍： Alzheimer''s & Dementia: Translational Research & Clinical Interventions (TRCI) is a peer-reviewed, open access,journal from the Alzheimer''s Association®. The journal seeks to bridge the full scope of explorations between basic research on drug discovery and clinical studies, validating putative therapies for aging-related chronic brain conditions that affect cognition, motor functions, and other behavioral or clinical symptoms associated with all forms dementia and Alzheimer''s disease. The journal will publish findings from diverse domains of research and disciplines to accelerate the conversion of abstract facts into practical knowledge: specifically, to translate what is learned at the bench into bedside applications. The journal seeks to publish articles that go beyond a singular emphasis on either basic drug discovery research or clinical research. Rather, an important theme of articles will be the linkages between and among the various discrete steps in the complex continuum of therapy development. For rapid communication among a multidisciplinary research audience involving the range of therapeutic interventions, TRCI will consider only original contributions that include feature length research articles, systematic reviews, meta-analyses, brief reports, narrative reviews, commentaries, letters, perspectives, and research news that would advance wide range of interventions to ameliorate symptoms or alter the progression of chronic neurocognitive disorders such as dementia and Alzheimer''s disease. The journal will publish on topics related to medicine, geriatrics, neuroscience, neurophysiology, neurology, psychiatry, clinical psychology, bioinformatics, pharmaco-genetics, regulatory issues, health economics, pharmacoeconomics, and public health policy as these apply to preclinical and clinical research on therapeutics.