ArticleBMC psychiatry2025
Study protocol for a randomized controlled trial assessing clinical efficacy of digital cognitive rehabilitation for preclinical and mild clinical stages of alzheimer's disease continuum: the MI-RICORDO project.
Article in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07064226 (Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4), which is not on this map. Not yet cited in PubMed.
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Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4
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10 authors.
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Abstract
backgroundEarly or preclinical stages of 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. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the efficacy and efficiency of a personalized, multidomain digital cognitive rehabilitation approach compared to conventional paper-and-pencil therapy. A secondary objective is to investigate the structural and functional neuroplasticity mechanisms associated with both interventions, using advanced magnetic resonance imaging techniques.
methodsThe study presents a single-blinded (assessors) 1:1 parallel-arm RCT design involving 102 patients with Subjective Cognitive Decline, o Mild Cognitive Impairment or early-stage dementia. For the experimental intervention group (EG) the digital therapeutic RICORDO-DTx will be employed, while the control group (CG) will perform an unstructured pencil-paper stimulation program. Both interventions will last 5 weeks with 3 session/week. Outcome measures will evaluate efficacy as changes in: behavioural and cognitive abilities, patients' engagement, and structural and functional neuroplasticity mechanisms by means of Magnetic Resonance Imaging. Additional evaluation 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 follow up six months post baseline (T2). Data analyses will involve repeated measures ANOVA models on primary and secondary outcome measures to compare efficacy of intervention between EG and CG. Finally, efficiency measures will be reported with descriptive statistics.
conclusionsThe expected results lay on the ability of RICORDO DTx, to adapt task difficulty automatically based on patients' performance and perceived difficulty. This adaptive approach is anticipated to yield superior treatment outcomes relative to traditional pencil-and-paper exercises.
trial registrationClinicalTrials.gov NCT07064226. Date of registration 30th July 2025.
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