Baseline characteristics and study progress of the CITA GO‐ON Study. A FINGER‐like Multidomain Intervention to Prevent Cognitive Decline in Spain

Abstract

AbstractBackgroundThe FINGER study demonstrated the efficacy of a non‐pharmacological multidomain intervention to prevent cognitive decline in at‐risk older adults. After a successful pilot feasibility study, in Q3 2021 we launched the CITA GO‐ON study, inspired by FINGER methodology to demonstrate the efficacy of a risk factor and lifestyles multimodal intervention to prevent cognitive decline in southern Europe. Here we describe the baseline characteristics of participants recruited in the study.MethodThe CITA GO‐ON study (ClinicalTrials.gov, NCT04840030) is a two‐year randomized, controlled trial. The primary aim is to reduce the risk of decline in cognitive functioning in the Neuropsychology Test Battery after two years by a multi‐modal intervention on risk factors and protective life‐styles as compared to standard health care. Inclusion criteria are: 60‐85 years old; CAIDE dementia risk score ≥ 6; cognitive frailty; no dementia. The multidomain intervention includes optimized control of cardiovascular risk factors; correction of polypharmacy; cognitive training; physical exercise program; socioemotional intervention; and promotion of adherence to the Mediterranean diet.ResultsTo date, 1964 individuals completed pre‐screening using self‐administered online survey in REDCap (Research Electronic Capture) and 874 (44.5%) fulfilled criteria for an in‐person screening visit. Screening was successful in 477 of participants. Mean (SD) age is 66.24 (4.99), 13.26 (4.43) years of education, MMSE 28.27 (1.78), CAIDE score 7.48 (1.36), and 235 (49%) are men. Based on CAIDE components, at baseline, 287 (60%) showed high systolic blood pressure, 165 (35%) low physical activity, 122 (26%) high BMI, and 101 (21%) with high cholesterol. Regarding cognitive frailty, 144 (31%) presented low performance on brief cognitive testing (Memory Alteration Test ≤ 40 and/or Fototest ≤ 35), 186 (39%) presented memory complaints (Cognitive Change Index ≥ 20), and 147 (30%) showed both criteria. Currently, 191 have been randomly assigned to the control and 192 to the Intervention groups. So far, adherence to intervention activities is high, ranging from 73% to 97%, depending on the modality.ConclusionCITA GO‐ON Study recruitment strategy includes participants with high risk of dementia based on modifiable factors and in situation of cognitive fragility, with might increase the probability of obtaining positive efficacy results.