PHysical ACtivity and Aminoacids in MCI: their role in progression towards DEmentia. Study design for “PHACADE”: a monocentric, prospective, non‐pharmacologic interventional study

Abstract

AbstractBackgroundMild cognitive impairment (MCI) is a condition in which individuals shows overt cognitive impairment with minimal impairment of instrumental activities of daily living (IADLs). Individuals with MCI have a 10‐fold increased risk of developing dementia as compared to cognitively normal individuals. Several factors are involved into progression from MCI to dementia and sarcopenia is one of them. Hence, physical exertion is an appropriate treatment for people with MCI. But older adults should integrate physical activity with a nutritional programme. The aim of our project is to evaluate the effect of physical training alone and combined physical training and dietary intervention on MCI progression towards AD.Methodopen‐label single centre trial. It compares two cohorts of patient with MCI during a follow‐up period of 2 years: 200 participants are divided in two cohorts (50 intervention group, 150 control group, 1:3 ratio). Inclusion criteria are being > = 65 years old with a diagnosis of MCI made upt to 6 months before the enrolment. Exclusion criteria are Tinetti Scale score of > = 24, Clinical Frailty Scale (CFS) < = 5 and concomitant psychiatric disorders or chronic alcoholism. For each participant in the control group, a twice a week plan of up to 40 minutes of aerobic exertion is conducted by a technician with a degree in sports science belonging to the UOC Medicina dello Sport of AUSL Modena Physical activity programme lasts two months and is scheduled at month 4, and then rescheduled at month 10, month 16 and month 21. In addition to the same twice‐a‐week physical activity exertion plan scheduled for the control group, a supplementation of essential amino acids pharmacological preparation, according to WHO daily ratio is furnished for participants in the intervention group. The main endpoint is to evaluate the efficacy, in terms of incidence rate ratio of developing an overt AD over a 24‐months period.Resultcurrently, the project has been approved by the ethic committe (AOU 0026789/22)) and the enrolment is ongoing.Conclusionthis study will provide more evidence about the efficacy and the feasibility of integrated physical exertion and nutrition programme in MCI population.