Supplementary Material for: Adequacy of Using Consensus Guidelines for Diagnosis of Dementia with Lewy Bodies in Clinical Trials for Drug Development

<b><i>Background/Aims:</i></b> To evaluate the adequacy of using the consensus diagnostic criteria for dementia with Lewy bodies (DLB) to recruit patients with homogeneous characteristics in future clinical trials, where multiple departments of multinational centres are expected to participate with a long enrolment period, and additionally, to contribute to the possible future criteria revision. <b><i>Methods:</i></b> Using data from 2 trials of donepezil for DLB, conducted 3 years apart, characteristics in patients with probable DLB were analysed and compared between studies and between psychiatric and neurological centres. <b><i>Results:</i></b> In 273 patients (phase II: 135, phase III: 138; psychiatric: 73, neurological: 184), clinical characteristics overall were very similar between studies, and between specialty centres, excluding distinctive parkinsonism in the neurological versus psychiatric centres: incidence of parkinsonism (91.8 vs. 71.2%, p &lt; 0.001), Hoehn and Yahr stage (III: 55.0 vs. 21.2%, p &lt; 0.001), and concomitant anti-Parkinson medication (24.5 vs. 11.0%, p = 0.017). Rapid eye movement sleep behaviour disorder, depression, and delusion, suggestive or supportive features, were observed in 35-40%. Additionally, a high prevalence (55.3%) of anxiety was observed. <b><i>Conclusion:</i></b> Employing the consensus criteria is adequate to enrol homogeneous DLB patients into future clinical trials regardless of the specialty of centres and time. Further discussion could involve adding anxiety to future criteria.**背景/目的：** 为评估采用路易体痴呆（dementia with Lewy bodies, DLB）共识诊断标准招募特征均一的患者，以开展未来跨国多中心、入组周期较长的临床试验的适用性，并为该诊断标准的未来修订提供依据。 **方法：** 基于两项间隔3年开展的多奈哌齐治疗路易体痴呆的临床试验数据，对很可能的路易体痴呆患者的临床特征进行分析，并比较不同试验间以及精神科与神经内科中心间的患者特征差异。 **结果：** 本研究共纳入273例患者（II期135例，III期138例；精神科来源73例，神经内科来源184例）。整体而言，除神经内科与精神科中心间的帕金森症状差异外，两项试验间以及不同专科中心间的患者临床特征均高度相似；二者的帕金森症状相关指标存在显著差异：帕金森症状发生率（91.8% vs. 71.2%，p<0.001）、霍恩-亚尔（Hoehn and Yahr）分期（III期占比55.0% vs. 21.2%，p<0.001）以及合并抗帕金森药物治疗的比例（24.5% vs. 11.0%，p=0.017）均存在统计学差异。作为提示或支持性特征的快速眼动睡眠行为障碍、抑郁及妄想症状的检出率为35%~40%。此外，本研究还观察到较高比例（55.3%）的焦虑症状。 **结论：** 无论参与试验的中心专科类型与试验开展时间如何，采用该共识诊断标准招募特征均一的路易体痴呆患者用于未来临床试验均具有适用性。后续可考虑将焦虑症状纳入该诊断标准的修订讨论范畴。