Feasibility, Safety, and Preliminary Efficacy of Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease: A 12-Month Pilot Randomized Controlled Trial

Background: Non-pharmacological interventions may enhance motor-cognitive integration in prodromal Alzheimer's disease (pAD). Partnered Rhythmic Rehabilitation (PRR), an adapted dance-based intervention, is designed to engage the motor, cognitive, and social domains. However, no randomized trial has evaluated its feasibility or efficacy in pAD. This study evaluated the feasibility, safety, and preliminary efficacy of PRR compared to group walking (WALK) in adults with pAD and amnestic mild cognitive impairment (aMCI). Methods: In this single-blind, randomized controlled pilot trial (NCT04029623), 68 adults with pAD and aMCI were randomized to PRR or WALK. Prespecified feasibility criteria were attrition [≤]15% and no injurious falls during interventions. Preliminary efficacy was examined on the primary outcome, the Four-Square Step Test (FSST). Secondary cognitive, motor, and psychosocial outcomes were also assessed to inform future definitive trials. Several modifications were made to the original protocol to ensure compliance with safety measures associated with the COVID-19 pandemic. Results: Attrition in the PRR group (15.2%) did not significantly exceed the prespecified threshold (P = .848), and 0 injurious falls were reported during the supervised sessions, meeting both feasibility and safety criteria. No significant group-by-time interactions were observed for FSST, but significant group-by-time interactions favoring PRR were identified for Timed Up-and-Go (TUG; P = .021) and jump distance (P = .014). Conclusion: PRR was feasible and safe in adults with aMCI consistent with pAD but did not meet the prespecified efficacy endpoint on FSST. Our results showed that TUG and standing board jump distance may serve as potential outcomes in future definitive trials.