Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)

© 2022 The Authors. Published by Elsevier Inc. on behalf of American College of Medical Genetics and Genomics. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Detalles Bibliográficos
Autores: Cieuta-Walti, Cécile, Cuenca, Aida, Langohr, Klaus|||0000-0001-7075-9192, Dierssen, Mara, De la Torre Fornell, Rafael
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Politècnica de Catalunya (UPC)
Repositorio:UPCommons. Portal del coneixement obert de la UPC
Idioma:inglés
OAI Identifier:oai:upcommons.upc.edu:2117/386528
Acceso en línea:https://hdl.handle.net/2117/386528
https://dx.doi.org/10.1016/j.gim.2022.06.011
Access Level:acceso abierto
Palabra clave:Children
Cognition
Down syndrome
EGCG
Safety
Àrees temàtiques de la UPC::Matemàtiques i estadística::Estadística aplicada
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spelling Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)Cieuta-Walti, CécileCuenca, AidaLangohr, Klaus|||0000-0001-7075-9192Dierssen, MaraDe la Torre Fornell, RafaelChildrenCognitionDown syndromeEGCGSafetyÀrees temàtiques de la UPC::Matemàtiques i estadística::Estadística aplicada© 2022 The Authors. Published by Elsevier Inc. on behalf of American College of Medical Genetics and Genomics. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Purpose: Although some caregivers are using epigallocatechin gallate (EGCG) off label in hopes of improving cognition in young adults with Down syndrome (DS), nothing is known about its safety, tolerability, and efficacy in the DS pediatric population. We aimed to evaluate safety and tolerability of a dietary supplement containing EGCG and if EGCG improves cognitive and functional performance. Methods: A total of 73 children with DS (aged 6-12 years) were randomized. Participants received 0.5% EGCG (10 mg/kg daily dose) or placebo for 6 months with 3 months follow up after treatment discontinuation. Results: In total, 72 children were treated and 66 completed the study. A total of 38 participants were included in theEGCGgroup and 35 in the placebo group. Of 72 treated participants, 62 (86%) had 229 treatment-emergent adverse events (AEs). Of 37 participants in the EGCG group, 13 (35%) had 18 drug-related treatment-emergent AEs and 12 of 35 (34%) from the placebo group had 22 events. In the EGCG group, neither severe AEs nor increase in the incidence of AEs related to safety biomarkers were observed. Cognition and functionality were not improved compared with placebo. Secondary efficacy outcomes in girls point to a need for future work. Conclusion: The use of EGCG is safe and well-tolerated in children with DS, but efficacy results do not support its use in this population.Peer ReviewedArticle signat per 26 autors/es: Cécile Cieuta-Walti, Aida Cuenca-Royo, Klaus Langohr, Claire Rakic, Ma Ángeles López-Vílchez, Julián Lirio, Domingo González-Lamuño Leguina, Teresa Bermejo González, Jordi García García, Maria Rimblas Roure, Ana Aldea-Perona, Laura Forcano, Maria Gomis-Gonzalez, Sebastià Videla Cés, Florence Lacaille, Aimé Ravel, Clotilde Mircher, Hervé Walti, Nathalie Janel, Julien Dairou, Marilyne Lévy, Sophie Durand, Mara Dierssen, Silvia Sacco, Rafael de la Torre Fornell, PERSEUS Study Group20222022-10-0120232023-04-21journal articlehttp://purl.org/coar/resource_type/c_6501AMhttp://purl.org/coar/version/c_ab4af688f83e57aainfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/2117/386528https://dx.doi.org/10.1016/j.gim.2022.06.011reponame:UPCommons. Portal del coneixement obert de la UPCinstname:Universitat Politècnica de Catalunya (UPC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:upcommons.upc.edu:2117/3865282026-05-27T15:37:01Z
dc.title.none.fl_str_mv Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
title Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
spellingShingle Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
Cieuta-Walti, Cécile
Children
Cognition
Down syndrome
EGCG
Safety
Àrees temàtiques de la UPC::Matemàtiques i estadística::Estadística aplicada
title_short Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
title_full Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
title_fullStr Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
title_full_unstemmed Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
title_sort Safety and preliminary efficacy on cognitive performance and adaptive functionality of epigallocatechin gallate (EGCG) in children with Down syndrome: a randomized phase Ib clinical trial (PERSEUS study)
dc.creator.none.fl_str_mv Cieuta-Walti, Cécile
Cuenca, Aida
Langohr, Klaus|||0000-0001-7075-9192
Dierssen, Mara
De la Torre Fornell, Rafael
author Cieuta-Walti, Cécile
author_facet Cieuta-Walti, Cécile
Cuenca, Aida
Langohr, Klaus|||0000-0001-7075-9192
Dierssen, Mara
De la Torre Fornell, Rafael
author_role author
author2 Cuenca, Aida
Langohr, Klaus|||0000-0001-7075-9192
Dierssen, Mara
De la Torre Fornell, Rafael
author2_role author
author
author
author
dc.subject.none.fl_str_mv Children
Cognition
Down syndrome
EGCG
Safety
Àrees temàtiques de la UPC::Matemàtiques i estadística::Estadística aplicada
topic Children
Cognition
Down syndrome
EGCG
Safety
Àrees temàtiques de la UPC::Matemàtiques i estadística::Estadística aplicada
description © 2022 The Authors. Published by Elsevier Inc. on behalf of American College of Medical Genetics and Genomics. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-10-01
2023
2023-04-21
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
AM
http://purl.org/coar/version/c_ab4af688f83e57aa
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/2117/386528
https://dx.doi.org/10.1016/j.gim.2022.06.011
url https://hdl.handle.net/2117/386528
https://dx.doi.org/10.1016/j.gim.2022.06.011
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:UPCommons. Portal del coneixement obert de la UPC
instname:Universitat Politècnica de Catalunya (UPC)
instname_str Universitat Politècnica de Catalunya (UPC)
reponame_str UPCommons. Portal del coneixement obert de la UPC
collection UPCommons. Portal del coneixement obert de la UPC
repository.name.fl_str_mv
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