{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T15:51:38Z","timestamp":1788537098817,"version":"build-2803163510"},"reference-count":40,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,3,31]],"date-time":"2021-03-31T00:00:00Z","timestamp":1617148800000},"content-version":"vor","delay-in-days":89,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["ISCIII PI17\/00223"],"award-info":[{"award-number":["ISCIII PI17\/00223"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["FI18\/00041"],"award-info":[{"award-number":["FI18\/00041"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["A&amp;D Transl Res &amp; Clin Interv"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Subjects exhibiting subjective cognitive decline (SCD) are at an increased risk for mild cognitive impairment and dementia. Given the delay between risk exposure and disease onset, SCD individuals are increasingly considered a good target population for cost\u2010effective lifestyle\u2010based Alzheimer's disease prevention trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The PENSA study is a randomized, double\u2010blind, controlled clinical trial that aims to evaluate the efficacy of a personalized multimodal intervention in lifestyle (diet counseling, physical activity, cognitive training, and social engagement) combined with the use of epigallocatechin gallate (EGCG) over 12 months, in slowing down cognitive decline and improving brain connectivity. The study population includes 200 individuals meeting SCD criteria and carrying the apolipoprotein E \u03b54 allele, who will be randomized into four treatment arms (multimodal intervention + EGCG\/placebo, or lifestyle recommendations + EGCG\/placebo). The primary efficacy outcome is change in the composite score for cognitive performance measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS\u2010PACC\u2010like) adding to the original version the Interference score from the Stroop Color and Word Test and the Five Digit Test. Secondary efficacy outcomes are (1) change in functional magnetic resonance imaging (fMRI) and structural neuronal connectivity (structural MRI) and (2) the safety assessment of the EGCG compound. This study is framed within the WW\u2010FINGERS consortium.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The use of new technologies (i.e., mobile ecological momentary assessments [EMAs], activity tracker) in the PENSA study allows the collection of continuous data on lifestyle behaviors (diet and physical activity) and mood, enabling a personalized design as well as an intensive follow\u2010up of participants. These data will be used to give feedback to participants about their own performance along the intervention, promoting their involvement and adherence. The results of the study may aid researchers on the design of future clinical trials involving preventive lifestyle multicomponent interventions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/trc2.12155","type":"journal-article","created":{"date-parts":[[2021,3,31]],"date-time":"2021-03-31T23:05:29Z","timestamp":1617231929000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Prevention of cognitive decline in subjective cognitive decline APOE \u03b54 carriers after EGCG and a multimodal intervention (PENSA): Study design"],"prefix":"10.1002","volume":"7","author":[{"given":"Laura","family":"Forcano","sequence":"first","affiliation":[{"name":"Integrative Pharmacology and Systems Neurosciences Research Group, Neurosciences Research Program Hospital del Mar Medical Research Institute (IMIM)  Barcelona Spain"},{"name":"CIBER de Fisiopatolog\u00eda de la Obesidad y la Nutrici\u00f3n (CIBEROBN) Instituto de Salud Carlos III  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karine","family":"Fauria","sequence":"additional","affiliation":[{"name":"Barcelona\u03b2eta Brain Research Center (BBRC) Pasqual Maragall Foundation  Barcelona Spain"},{"name":"CIBER de Fragilidad y Envejecimiento Saludable (CIBERFES) Instituto de Salud Carlos III  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia","family":"Soldevila\u2010Domenech","sequence":"additional","affiliation":[{"name":"Integrative Pharmacology and Systems Neurosciences Research Group, Neurosciences Research Program Hospital del Mar Medical Research Institute (IMIM)  Barcelona Spain"},{"name":"Department of Experimental and Health Sciences University Pompeu Fabra  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Minguill\u00f3n","sequence":"additional","affiliation":[{"name":"Barcelona\u03b2eta Brain Research Center (BBRC) Pasqual Maragall Foundation  Barcelona Spain"},{"name":"CIBER de Fragilidad y Envejecimiento Saludable (CIBERFES) Instituto de Salud Carlos III  Madrid Spain"},{"name":"Physiology of Cognition and Alzheimer's Prevention Research Group, Neurosciences Research Program Hospital del Mar Medical Research Institute (IMIM)  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thais","family":"Lorenzo","sequence":"additional","affiliation":[{"name":"Integrative Pharmacology and Systems Neurosciences Research Group, Neurosciences Research Program Hospital del Mar Medical Research Institute (IMIM)  Barcelona Spain"},{"name":"Department of Experimental and Health Sciences University Pompeu Fabra  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aida","family":"Cuenca\u2010Royo","sequence":"additional","affiliation":[{"name":"Integrative Pharmacology and Systems Neurosciences Research Group, Neurosciences Research Program Hospital del Mar Medical 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 Barcelona Spain"},{"name":"CIBER de Fisiopatolog\u00eda de la Obesidad y la Nutrici\u00f3n (CIBEROBN) Instituto de Salud Carlos III  Madrid Spain"},{"name":"Department of Experimental and Health Sciences University Pompeu Fabra  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"PENSA Study Group\u01c2","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,31]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"World Alzheimer Report 2018: The State of the Art of Dementia Research: New frontiers","author":"ADI. 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