The In-TeMPO project – Multidomain intervention for the prevention of cognitive decline is a multicenter research initiative funded by the PNRR and coordinated by the University of Milan-Bicocca, which aims to evaluate the effectiveness of an integrated intervention across multiple domains – physical activity, cognitive training, nutrition, sleep, and hearing health – in preventing and slowing cognitive decline in the elderly population. The study design involves a randomized case-control clinical trial with a total of 150 participants for each center, with the primary outcome being cognitive performance and secondary outcomes including inflammatory biomarkers, sleep quality, nutritional status, hearing function, and brain imaging.
The project structure is divided into several operational sites distributed throughout the country, including two hubs in southern Italy:
In-TeMPO WS (Western Sicily), based at the University of Palermo, is responsible for the design and implementation of the neurogeriatric protocol, the selection and dosage of inflammatory and endothelial biomarkers (via ELISA), and the development of the neuroimaging protocol using 3T MRI, with advanced morphological and functional analysis (including icobrain software).
In-TeMPO SO (Southern Operational), based at the University of Catania, is responsible for harmonizing neuropsychological screening tools, defining and testing nutritional and audiological tools, selecting actigraphs for sleep monitoring, and managing recruitment in close collaboration with local general practitioners (GPs).
The project aims to generate solid and replicable scientific evidence to support new multidimensional cognitive prevention strategies that are sustainable and transferable to clinical practice and public health contexts.
29 July – 28 November 2024
The In-TeMPO WS – Western Sicily project (University of Palermo, part of the national In-TeMPO PNRR network) aims to assess the effectiveness of a multidomain intervention—combining physical exercise, cognitive training, nutritional support, sleep hygiene, and hearing management—in improving the cognitive performance of 150 older adults at risk of cognitive decline, while also examining secondary outcomes related to plasma biomarkers, neuroimaging measures, sleep quality, nutrition, and auditory health.
During the first reporting quarter, following a remodulation of the project design (streamlining from five to four work packages and formal integration into the national multicentre network coordinated by the University of Milano-Bicocca), preparatory activities were completed. These included the development of the neurogeriatric clinical protocol, preparation of documentation for submission to the local Ethics Committee (CEL1), weekly training sessions for medical, psychological, and nursing staff, selection of inflammatory and endothelial biomarkers for ELISA assays, and the finalisation of 3T MRI protocols for morphological, perfusion, and connectivity analyses, with planned volumetric assessments using icobrain software.
The screening and recruitment of participants (75 intervention, 75 controls) was postponed to the second quarter, pending completion of the ethics approval process and the activation of the centralised REDCAP platform for data management. Methodological milestones have been achieved in line with the revised project timeline