INTRODUCTIONNon‐pharmacological interventions may offer significant benefits to the quality of life for persons with primary progressive aphasia (PPA) and their care partners but have lacked efficacy trials. To help fill the efficacy gap, we provide the feasibility of recruitment, enrollment, randomization, and baseline data for the Communication Bridge‐2 (CB2) randomized controlled trial (RCT).METHODSCB2 is the first international, single enrollment site, Phase 2, Stage 2, parallel‐group, active control, RCT delivered via video chat to individuals with PPA and their care partners. Participants were recruited, screened, and randomized into one of two speech–language intervention arms.RESULTSNinety‐five participant dyads (PPA mean baseline age: 67.1; 48% female) from four countries were enrolled and randomized.DISCUSSIONGlobal recruitment, enrollment, and randomization of individuals with PPA into a video chat–delivered non‐pharmacologic RCT is feasible. This trial provides a potential model for conducting rigorous non‐pharmacologic efficacy trials for Alzheimer's disease and related dementias.Highlights Primary progressive aphasia (PPA) negatively impacts communication participation. Communication Bridge‐2 (CB2) is a telemedicine‐delivered randomized controlled trial. CB2 included global recruitment and randomization of 95 PPA participant dyads. CB2, the first international superiority trial for PPA using video chat shows feasibility. The study provides a model for rigorous non‐pharmacologic trials for Alzheimer's disease and related dementias.

中文翻译：

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Communication Bridge-2 随机对照试验：招募和基线特征


引言 药物干预可能为原发性进行性失语症 （PPA） 患者及其护理伙伴的生活质量提供显着益处，但缺乏疗效试验。为了帮助填补疗效差距，我们为 Communication Bridge-2 （CB2） 随机对照试验 （RCT） 提供了招募、入组、随机化和基线数据的可行性。METHODSCB2 是通过视频聊天向 PPA 患者及其护理伙伴提供的第一个国际、单一注册站点、第 2 阶段、平行组、主动对照、随机对照试验。参与者被招募、筛选并随机分配到两个言语-语言干预组之一。结果来自 4 个国家的 10 名参与者二人组 （PPA 平均基线年龄： 67.1;48% 为女性） 被纳入并随机分组。讨论将 PPA 患者随机招募、入组和随机分配到视频聊天交付的非药物 RCT 中是可行的。该试验为对阿尔茨海默病和相关痴呆症进行严格的非药物疗效试验提供了一种潜在模型。亮点 原发性进行性失语症 （PPA） 对沟通参与产生负面影响。Communication Bridge-2 （CB2） 是一项远程医疗提供的随机对照试验。CB2 包括 95 个 PPA 参与者二元组的全球招募和随机化。CB2 是第一个使用视频聊天的 PPA 国际优效性试验，显示了可行性。该研究为阿尔茨海默病和相关痴呆症的严格非药物试验提供了一个模型。