Clinical Research Directory

PotenziaMente: A Digital Executive Function Training Intervention for Healthy Aging in the Elderly Population

The study, entitled "PotenziaMente: Cognitive Training in Aging," is a clinical trial designed to evaluate the effectiveness of an individualized tablet-based cognitive training program targeting executive functions (e.g., planning, cognitive flexibility, and problem solving) in healthy older adults. Executive functions are higher-order cognitive processes that support adaptive functioning in daily life and influence other cognitive domains, such as memory. The primary aim of the study is to enhance cognitive performance, specifically executive abilities, in neurologically healthy adults aged 65 to 75 years. A secondary aim is to compare whether there are differences in the effects of two different delivery modalities of the same cognitive training program: home-based self-administration via tablet versus supervised tablet-based training in the presence of a trained researcher. Participants will undergo cognitive assessments at baseline (pre-training), immediately after the intervention (post-training), and at a 3-month follow-up. This is a randomized parallel-group interventional clinical trial with no masking. Participants are randomly assigned to one of two groups: a home-based cognitive training condition, in which they perform an individualized tablet-based cognitive training program targeting executive functions independently at home via a tablet application without direct supervision, or a supervised cognitive training condition, in which they perform the same individualized tablet-based cognitive training under the supervision of a trained researcher in a controlled environment. The intervention consists of two sessions per week, 1 hour per session, for 4 consecutive weeks, delivered via tablet-based exercises. The study uses a parallel assignment model with a prospective time perspective and a primary purpose of treatment (cognitive enhancement / prevention of cognitive decline). The primary outcome is the change in executive functions from baseline to post-intervention, assessed using standardized neuropsychological tests. Secondary outcomes include between-group differences (home-based vs supervised) in executive function performance, changes in global cognitive functioning from baseline to post-intervention, and maintenance of cognitive effects at the 3-month follow-up.