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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; Elsevier BV; Volume: 24; Issue: 10 Linguagem: Inglês

10.1016/j.gim.2022.06.011

1530-0366

Cécile Cieuta‐Walti, Aida Cuenca‐Royo, Klaus Langohr, Claire Rakic, Ma Ángeles López-Vílchez, Julián Lirio, Domingo González‐Lamuño, Teresa Bermejo González, Jordi García García, Maria Rimblas Roure, Ana Aldea‐Perona, Laura Forcano, María Gomis-González, Sebastián Videla, Florence Lacaille, Aimé Ravel, Clotilde Mircher, Hervé Walti, Nathalie Janel, Julien Dairou, Marilyne Lévy, Sophie Durand, Mara Dierssen, Silvia Sacco, Rafael de la Torre, I. Álvarez Guerrico, Albert Goday, Cristina Llop, Julián Mateus, Iris Matilla, Esther, Menoyo, Lorena Hernández-Ligero, Marta Drake-Pérez, Neus Pizarro, Alessandro Príncipe, A. Cortesi, A González Gómez, Noelia Paredes, Cristina Gómez, Montserrat Graell, Pilar Sáez-López, Rosario Morales Lozano, Constancio Medrano, Maria Teresa Andrade-Navarro, Gema Daza, Sandra Garcia, M. Gayan, Cristina Guerra-Colorado, Beatriz Luna, Enriqueta Maya, Delia Millan, M.V. Camacho Reina, María Teresa Amigo, José Luís Fernández, María García‐Martínez, María del Socorro Pérez-Poyato, Ana Pozueta, Emma Tato, María Teresa Viadero, Magnolia Akkaya, Ségolène Falquero, A Gambarini, Magnolia Akkaya, Ségolène Falquero, A Gambarini,

Frailty in Older Adults

PurposeAlthough 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.MethodsA 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.ResultsIn total, 72 children were treated and 66 completed the study. A total of 38 participants were included in the EGCG group 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.ConclusionThe use of EGCG is safe and well-tolerated in children with DS, but efficacy results do not support its use in this population.