Clinical Trial to Evaluate Digital Cognitive Rehabilitation for Early Alzheimer's and Cognitive Decline
Source PublicationBMC Psychiatry
Primary AuthorsBlasi, Isernia, Rossetto et al.
Early or preclinical stages of the AD continuum may benefit from lifestyle interventions and cognitive rehabilitation strategies that can delay or prevent progression to dementia. In this context, digital health technologies offer a disruptive potential to expand access to cognitive rehabilitation and meet the increasing demand for early interventions. As lead author Blasi notes in the paper, "In this context, digital health technologies offer a disruptive potential to expand access to cognitive rehabilitation and meet the increasing demand for early interventions."
This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the efficacy and efficiency of a personalized, multidomain digital cognitive rehabilitation approach. This trial directly compares the digital therapeutic RICORDO-DTx against conventional paper-and-pencil therapy. The study presents a single-blinded (assessors) 1:1 parallel-arm RCT design involving 102 patients with Subjective Cognitive Decline, Mild Cognitive Impairment, or early-stage dementia. For the experimental intervention group, RICORDO-DTx will be employed, while the control group will perform an unstructured pencil-paper stimulation program. Both interventions will last five weeks, with three sessions per week.
The study's outcome measures will evaluate efficacy as changes in behavioral and cognitive abilities, patient engagement, and structural and functional neuroplasticity mechanisms, utilizing advanced Magnetic Resonance Imaging techniques. A secondary objective is to investigate these neuroplasticity mechanisms associated with both interventions. Additionally, the trial will include efficiency measures related to usability, acceptability, safety, sustainability, and user experience. Patients will be evaluated at baseline (T0), after treatment (T1), and at a six-month follow-up (T2). Data analyses will involve repeated measures ANOVA models to compare the efficacy of the interventions.
The expected results of the study hinge on the adaptive capabilities of RICORDO-DTx. The digital therapeutic is designed to automatically adapt task difficulty based on patients' performance and perceived difficulty. This adaptive approach is anticipated to yield superior treatment outcomes relative to traditional pencil-and-paper exercises.