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Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design

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dc.contributor.author Forcano, Laura
dc.contributor.author Fauria, Karine
dc.contributor.author Soldevila-Domenech, Natalia
dc.contributor.author Minguillón, Carolina
dc.contributor.author Lorenzo, Thais
dc.contributor.author Cuenca Royo, Aida Ma, 1981-
dc.contributor.author Menezes Cabral, Sofia
dc.contributor.author Pizarro Lozano, Mª Nieves
dc.contributor.author Boronat Rigol, Anna, 1990-
dc.contributor.author Molinuevo, José Luis
dc.contributor.author Torre Fornell, Rafael de la
dc.contributor.author PENSA Study Group
dc.date.accessioned 2021-08-27T08:13:47Z
dc.date.available 2021-08-27T08:13:47Z
dc.date.issued 2021
dc.identifier.citation Forcano L, Fauria K, Soldevila-Domenech N, Minguillón C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N, Boronat A, Molinuevo JL, de la Torre R; PENSA Study Group. Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimers Dement (N Y). 2021;7(1):e12155. DOI: 10.1002/trc2.12155
dc.identifier.issn 2352-8737
dc.identifier.uri http://hdl.handle.net/10230/48340
dc.description.abstract Introduction: 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-effective lifestyle-based Alzheimer's disease prevention trials. Methods: The PENSA study is a randomized, double-blind, 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 ε4 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-PACC-like) 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-FINGERS consortium. Discussion: 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-up 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.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Wiley
dc.relation.ispartof Alzheimers Dement (N Y). 2021;7(1):e12155
dc.rights © 2021 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals LLC on behalf of Alzheimer's Association. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.title Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1002/trc2.12155
dc.subject.keyword PENSA study
dc.subject.keyword Apolipoprotein E ε4
dc.subject.keyword Epigallocatechin gallate
dc.subject.keyword Lifestyle multimodal intervention
dc.subject.keyword Preclinical Alzheimer's disease
dc.subject.keyword Prevention
dc.subject.keyword Randomized clinical trial
dc.subject.keyword Subjective cognitive decline
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion


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