RESUMEN
Background and aims: Many clinical trials on potentially disease-modifying drugs are focused to mild cognitive impairment (MCI) prodromal-to-Alzheimer's disease. The MCI population actually includes patients with higher risk of progression to AD. Since the new drugs, if effective, will carry both elevated unit costs and not marginal side effects, they should be administered selectively to high-risk subjects. The Italian INTERCEPTOR project, promoted by the Italian Medicine Agency and the Italian Ministry of Health, is a multicenter, interventional, nontherapeutic cohort study in subjects with MCI, with the primary aim of identifying biomarkers that better predict the conversion to AD after 3 years of follow-up. Methods: A sample of 500 subjects with MCI was planned to be enrolled. The biomarkers under investigation obtained by the analysis of MMSE, CSF, FDG-PET, FCRST, APOE4, EEG, Volumetric MRI. Multivariate prediction model will provide the predictive performance of each biomarker and combinations. In applying biomarkers, three scenarios are considered: 1) use of cut-offs indicated by experts 2) defining new optimal cut-offs for the specific population 3) use of values in a continuous form in order to evaluate all predictive information. Finally, nomograms will be defined for use in clinical practice. Results: Due to COVID-19, the target sample size was not reached. The enrolment was closed on October 31st 2020. Overall 498 patients were screened, 362 recruited into the study and 17 dropped out. Conclusions: The findings will support the diagnostic path redefinition to identify those patients in the early stage eligible to prescription for disease-modifying medications.
RESUMEN
The SARS-CoV-2 pandemic shows that residential care setting is the epicenter of this tragedy. The National Observatory of Dementia at the Italian National Institute of Health has conducted from 24 March to 5 May 2020 a survey in the 3,417 nursing home for the elderly. 1,356 (41.3%) structures replied to the survey;in 393 (29%) of these, the SARS-CoV-2 virus has been documented. The results show that out of 9,154 people who died from February 1st to day of participation in the survey, 7.4% were affected by COVID-19 and 33.8% had flu-like symptoms. An integrated public health approach is urgent to understand the real dimensions of the phenomenon.
RESUMEN
The COVID-19 outbreak is having a profound impact on the health and well-being of people with dementia. In Italy and in other world countries a high percentage of COVID-19-related deaths have occurred in people with dementia. A large proportion of patients, although not directly affected by the contagion, experienced a significant worsening of their clinical conditions. In parallel, the levels of stress for family members and caregivers has increased considerably. Finally, the organization of clinical and social care activities and services for people with dementia and their caregivers has been profoundly subverted by the pandemic.