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Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design
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 A...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012239/ https://www.ncbi.nlm.nih.gov/pubmed/33816762 http://dx.doi.org/10.1002/trc2.12155 |
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author | Forcano, Laura Fauria, Karine Soldevila‐Domenech, Natalia Minguillón, Carol Lorenzo, Thais Cuenca‐Royo, Aida Menezes‐Cabral, Sofia Pizarro, Nieves Boronat, Anna Molinuevo, José Luis de la Torre, Rafael |
author_facet | Forcano, Laura Fauria, Karine Soldevila‐Domenech, Natalia Minguillón, Carol Lorenzo, Thais Cuenca‐Royo, Aida Menezes‐Cabral, Sofia Pizarro, Nieves Boronat, Anna Molinuevo, José Luis de la Torre, Rafael |
author_sort | Forcano, Laura |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8012239 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-80122392021-04-02 Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design Forcano, Laura Fauria, Karine Soldevila‐Domenech, Natalia Minguillón, Carol Lorenzo, Thais Cuenca‐Royo, Aida Menezes‐Cabral, Sofia Pizarro, Nieves Boronat, Anna Molinuevo, José Luis de la Torre, Rafael Alzheimers Dement (N Y) Research Articles 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. John Wiley and Sons Inc. 2021-03-31 /pmc/articles/PMC8012239/ /pubmed/33816762 http://dx.doi.org/10.1002/trc2.12155 Text en © 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 http://creativecommons.org/licenses/by-nc-nd/4.0/ 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. |
spellingShingle | Research Articles Forcano, Laura Fauria, Karine Soldevila‐Domenech, Natalia Minguillón, Carol Lorenzo, Thais Cuenca‐Royo, Aida Menezes‐Cabral, Sofia Pizarro, Nieves Boronat, Anna Molinuevo, José Luis de la Torre, Rafael Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title | Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title_full | Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title_fullStr | Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title_full_unstemmed | Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title_short | Prevention of cognitive decline in subjective cognitive decline APOE ε4 carriers after EGCG and a multimodal intervention (PENSA): Study design |
title_sort | prevention of cognitive decline in subjective cognitive decline apoe ε4 carriers after egcg and a multimodal intervention (pensa): study design |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012239/ https://www.ncbi.nlm.nih.gov/pubmed/33816762 http://dx.doi.org/10.1002/trc2.12155 |
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