Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, Malmö, Sweden.
Department of Neurology, Skåne University Hospital, Lund, Sweden.
JAMA Neurol. 2023 Jul 1;80(7):749-756. doi: 10.1001/jamaneurol.2023.1323.
It is important to determine the added clinical value for tau positron emission tomography (PET) in the diagnostic workup of patients with cognitive symptoms before widespread implementation in clinical practice.
To prospectively study the added clinical value of PET detecting tau pathology in Alzheimer disease (AD).
DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study (Swedish BioFINDER-2 study) took place from May 2017 through September 2021. A total of 878 patients with cognitive complaints were referred to secondary memory clinics in southern Sweden and then recruited to the study. In total, 1269 consecutive participants were approached, but 391 did not meet inclusion criteria or did not complete the study.
Participants underwent a baseline diagnostic workup, including clinical examination, medical history, cognitive testing, blood and cerebrospinal fluid sampling, magnetic resonance imaging of the brain, and a tau PET ([18F]RO948) scan.
The primary end points were change in diagnosis and change in AD drug therapy or other drug treatment between the pre- and post-PET visits. A secondary end point was the change in diagnostic certainty between the pre- and post-PET visits.
A total of 878 participants with a mean age of 71.0 (SD, 8.5) years (491 male [56%]) were included. The tau PET result led to a change in diagnoses in 66 participants (7.5%) and a change in medication in 48 participants (5.5%). The study team found an association with overall increased diagnostic certainty after tau PET in the whole data set (from 6.9 [SD, 2.3] to 7.4 [SD, 2.4]; P < .001). The certainty was higher in participants with a pre-PET diagnosis of AD (from 7.6 [SD, 1.7] to 8.2 [SD, 2.0]; P < .001) and increased even further in participants with a tau PET positive result supporting an AD diagnosis (from 8.0 [SD, 1.4] to 9.0 [SD, 0.9]; P < .001). The association with tau PET results had the largest effect sizes in participants with pathological amyloid-β (Aβ) status, whereas no significant change in diagnoses was seen in participants with normal Aβ status.
The study team reported a significant change in diagnoses and patient medication when tau PET was added to an already extensive diagnostic workup that included cerebrospinal fluid AD biomarkers. Including tau PET was associated with a significant increase in certainty of underlying etiology. The effect sizes for certainty of etiology and diagnosis were largest in the Aβ-positive group and the study team suggests that clinical use of tau PET be limited to populations with biomarkers indicating Aβ positivity.
在广泛应用于临床实践之前，确定 tau 正电子发射断层扫描（PET）在认知症状患者的诊断中的附加临床价值非常重要。
前瞻性研究 tau PET 检测在阿尔茨海默病（AD）中的附加临床价值。
设计、地点和参与者：这是一项前瞻性队列研究（瑞典 BioFINDER-2 研究），于 2017 年 5 月至 2021 年 9 月进行。共有 878 名有认知症状的患者被转诊到瑞典南部的二级记忆诊所，然后被招募入组。共有 1269 名连续参与者被邀请，但 391 名不符合纳入标准或未完成研究。
参与者接受了基线诊断评估，包括临床检查、病史、认知测试、血液和脑脊液采样、大脑磁共振成像和 tau PET（[18F]RO948）扫描。
主要终点是在 PET 前后就诊期间诊断的变化以及 AD 药物治疗或其他药物治疗的变化。次要终点是在 PET 前后就诊期间诊断确定性的变化。
共纳入 878 名平均年龄 71.0（SD，8.5）岁（491 名男性[56%]）的参与者。tau PET 结果导致 66 名参与者（7.5%）的诊断发生变化，48 名参与者（5.5%）的药物治疗发生变化。研究小组发现，tau PET 后整个数据集的诊断确定性总体上有所提高（从 6.9[SD，2.3]到 7.4[SD，2.4]；P<0.001）。在 tau PET 前 AD 诊断的参与者中，确定性更高（从 7.6[SD，1.7]到 8.2[SD，2.0]；P<0.001），tau PET 阳性结果支持 AD 诊断的参与者的确定性甚至进一步提高（从 8.0[SD，1.4]到 9.0[SD，0.9]；P<0.001）。tau PET 结果与淀粉样蛋白-β（Aβ）状态的病理结果相关性最大，而在 Aβ 正常的参与者中，诊断无明显变化。
研究小组报告称，当 tau PET 被添加到包括脑脊液 AD 生物标志物在内的广泛诊断评估中时，诊断和患者用药会发生显著变化。tau PET 的加入与潜在病因确定性的显著增加相关。病因和诊断确定性的效应大小在 Aβ 阳性组中最大，研究小组建议将 tau PET 的临床应用限于生物标志物表明 Aβ 阳性的人群。
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