PENSA study for the prevention of cognitive decline in APOE‐ɛ4 carriers with subjective cognitive decline: Description of baseline demographic and neuropsychological data of the study population

Abstract Background Alzheimer’s disease (AD) is a multifactorial disorder likely caused by a complex interplay of different pathological processes that are influenced by internal and external determinants. In the absence of effective treatments to reverse cognitive deterioration related to AD, there is a need to develop novel non‐pharmacological prevention interventions that may delay or prevent these pathological processes at early preclinical stages of AD. The PENSA study, framed within the WW‐FINGERS consortium, is a randomized clinical trial involving cognitively normal elderly individuals with an increased risk of developing AD (meeting subjective cognitive decline, SCD‐plus criteria and being APOE‐ɛ4 carriers). The aim of the study is to evaluate the efficacy of a multimodal personalized lifestyle intervention (dietary and physical activity counseling and cognitive training) combined with a dietary supplement, epigallocatechin gallate (EGCG) in slowing down cognitive decline. Method Baseline sociodemographic, mood and cognitive characteristics of the entire study sample participants is presented. Cognitive function was measured with the Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS‐PACC) and adding to this original version the interference score from the Stroop Color and Word Test and the Five Digit Test (ADCS‐PACC‐Plus‐exe). Additionally, the Digit Span, the Boston Naming Test and the Animal Fluency Test were administered. Psychological distress was measured with the Hospital Anxiety and Depression Scale. Result On Desember 2021 the study had enrolled 128 individuals (64.8% women) with a mean (SD) age of 67.3 (4.73) years and the following APOE genotype: 87% ɛ3/ɛ4, 7% ɛ4/ɛ4 and 6% ɛ2/ɛ4. Most had higher education (44.1%) and 81.9% were retired ( Table 1 ). 11% of participants exhibited relevant anxiety and depressive symptoms measured by the Hospital Anxiety and Depression Scale. According to an ad‐hoc SCD questionnaire, 65.8% of participants referred memory centered complaints. Considering the different domains, participants reported alterations on memory (97.6%), concentration (62.6%), language (69.9%) and visuospatial skills (10.6%). Table 2 shows the ADCS‐PACC‐Plus‐exe scores Conclusion The PENSA study will help shed light on the effectiveness of lifestyle interventions supplemented with EGCG to prevent cognitive decline in people at risk of developing AD.