Pontecorvo Michael J, Siderowf Andrew, Dubois Bruno, Doraiswamy P Murali, Frisoni Giovanni B, Grundman Michael, Nobili Flavio, Sadowsky Carl H, Salloway Stephen, Arora Anupa K, Chevrette Antoine, Deberdt Walter, Dell'Agnello Grazia, Flitter Matthew, Galante Nick, Lowrey Mark J, Lu Ming, McGeehan Anne, Devous Michael D, Mintun Mark A
Avid Radiopharmaceuticals (a wholly owned subsidiary of Eli Lilly and Company), Philadelphia, PA, USA.
Dement Geriatr Cogn Disord. 2017;44(3-4):129-143. doi: 10.1159/000478007. Epub 2017 Aug 5.
To evaluate the impact of amyloid PET imaging on diagnosis and patient management in a multicenter, randomized, controlled study.
Physicians identified patients seeking a diagnosis for mild cognitive impairment or dementia, possibly due to Alzheimer disease (AD), and recorded a working diagnosis and a management plan. The patients underwent florbetapir PET scanning and were randomized to either immediate or delayed (1-year) feedback regarding amyloid status. At the 3-month visit, the physician updated the diagnosis and recorded a summary of the actual patient management since the post-scan visit. The study examined the impact of immediate versus delayed feedback on patient diagnosis/management at 3 and 12 months.
A total of 618 subjects were randomized (1:1) to immediate or delayed feedback arms, and 602 subjects completed the 3-month primary endpoint visit. A higher proportion of patients in the immediate feedback arm showed a change in diagnosis compared to the controls (32.6 vs. 6.4%; p = 0.0001). Similarly, a higher proportion of patients receiving immediate feedback had a change in management plan (68 vs. 55.5%; p < 0.002), mainly driven by changes in AD medication. Specifically, acetylcholinesterase inhibitors were prescribed to 67% of the amyloid-positive and 27% of the amyloid-negative subjects in the information group compared with 56 and 43%, respectively, in the control group (p < 0.0001). These between-group differences persisted until the 12-month visit.
Knowledge of the amyloid status affects the diagnosis and alters patient management.
在一项多中心、随机、对照研究中评估淀粉样蛋白PET成像对诊断和患者管理的影响。
医生识别出可能因阿尔茨海默病(AD)而寻求轻度认知障碍或痴呆诊断的患者,并记录初步诊断和管理计划。患者接受氟比他哌PET扫描,并被随机分为立即或延迟(1年)获得淀粉样蛋白状态反馈两组。在3个月的随访中,医生更新诊断并记录自扫描后随访以来实际患者管理的总结。该研究考察了立即反馈与延迟反馈对3个月和12个月时患者诊断/管理的影响。
共有618名受试者被随机(1:1)分为立即反馈组或延迟反馈组,602名受试者完成了3个月的主要终点随访。与对照组相比,立即反馈组中有更高比例的患者诊断发生了变化(32.6%对6.4%;p = 0.0001)。同样,接受立即反馈的患者中有更高比例的人管理计划发生了变化(68%对55.5%;p < 0.002),主要由AD药物治疗的变化驱动。具体而言,信息组中67%的淀粉样蛋白阳性受试者和27%的淀粉样蛋白阴性受试者被开具了乙酰胆碱酯酶抑制剂,而对照组中这一比例分别为56%和43%(p < 0.0001)。这些组间差异一直持续到12个月随访。
淀粉样蛋白状态的信息会影响诊断并改变患者管理。