Rafael de la Torre|Susana Solá|Gimena Hernández|Mag?? Farré|Jesús Pujol|Joaquín Rodríguez|Josep M. Espadaler|Klaus Langohr|Aida Cuenca?Royo|Alessandro Príncipe|Laura Xicota|Nathalie Janel|Silvina Catuara?Solarz|Gonzalo Sánchez?Benavides|Henri Bléhaut|Iván Dueñas-Espín|Laura del Hoyo|Bessy Benejam|Laura Blanco?Hinojo|Sebastià Videla|Montserrat Fitó|Jean Maurice Delabar|Mara Dierssen
Safety and efficacy of cognitive training plus epigallocatechin-3-gallate in young adults with Down's syndrome (TESDAD): a double-blind, randomised, placebo-controlled, phase 2 trial
Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Universitat Autònoma de Barcelona|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Hospital Del Mar|Hospital del Mar Research Institute|Centro de Investigación Biomédica en Red de Salud Mental|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Hospital Del Mar|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Universitat Politècnica de Catalunya|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Hospital Del Mar|Hospital del Mar Research Institute|Centro de Investigación Biomédica en Red de Salud Mental|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Sorbonne Paris Cité|Université Paris Cité|French National Centre for Scientific Research|Pompeu Fabra University|Centre for Biomedical Network Research on Rare Diseases|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Fondation Jérôme-Lejeune|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Unió Catalana de Centres de Desenvolupament Infantil i Atenció Precoç|Hospital Del Mar|Hospital del Mar Research Institute|Centro de Investigación Biomédica en Red de Salud Mental|Unió Catalana de Centres de Desenvolupament Infantil i Atenció Precoç|Pompeu Fabra University|Pompeu Fabra University|Hospital del Mar Research Institute|Municipal Institute for Medical Research|Sorbonne Paris Cité|Université Paris Cité|French National Centre for Scientific Research|Institut du Cerveau|Inserm|Sorbonne Université|Pompeu Fabra University|Centre for Biomedical Network Research on Rare Diseases
background early cognitive intervention routine therapeutic approach used amelioration intellectual deficits individuals downs syndrome effects limited hypothesised administration green tea extract containing epigallocatechin3gallate egcg would improve effects nonpharmacological cognitive rehabilitation young adults downs syndrome methods enrolled adults aged 1634 years downs syndrome outpatient settings catalonia spain downs syndrome genetic variations trisomy 21 partial trisomy mosaic translocation doubleblind placebocontrolled phase 2 single centre trial tesdad participants randomly assigned imimhospital del mar medical research institute receive egcg 9 mgkg per day placebo cognitive training 12 months followed participants 6 months treatment discontinuation randomly assigned participants using randomnumber tables balanced allocation sex intellectual quotient participants families researchers assessing participants masked treatment allocation primary endpoint cognitive improvement assessed neuropsychologists battery cognitive tests episodic memory executive function functional measurements analysis intentiontotreat basis trial registered clinicaltrialsgov number nct01699711 findings study done june 5 2012 june 6 2014 84 87 participants downs syndrome included intentiontotreat analysis 12 months 43 egcg cognitive training group 41 placebo cognitive training group differences groups significant 13 15 tests tesdad battery eight nine adaptive skills adaptive behavior assessment system ii abasii 12 months participants treated egcg cognitive training significantly higher scores visual recognition memory pattern recognition memory test immediate recall adjusted mean difference 623 percentage points 95 ci 031 1214 p0039 04 005 084 inhibitory control cats dogs total score adjusted mean difference 048 002 093 p0041 028 019 074 cats dogs total response time adjusted mean difference 458 854 062 p0024 027 072 020 adaptive behaviour abasii functional academics score adjusted mean difference 549 213 886 p0002 039 006 084 differences noted adverse effects two treatment groups interpretation egcg cognitive training 12 months significantly effective placebo cognitive training improving visual recognition memory inhibitory control adaptive behaviour phase 3 trials larger population individuals downs syndrome needed assess confirm longterm efficacy egcg cognitive training funding jrme lejeune foundation instituto de salud carlos iii feder mineco generalitat de catalunya