Communication Bridge-2 randomized controlled trial: Recruitment and baseline features

Introduction: Non-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).

Methods: CB2 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.

Results: Ninety-five participant dyads (PPA mean baseline age: 67.1; 48% female) from four countries were enrolled and randomized.

Discussion: Global 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.