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dc.contributor.authorDe la Torre Fornell, Rafael
dc.contributor.authorde Sola Llopis, Susana
dc.contributor.authorHernández, Gimena
dc.contributor.authorFarré, Magí
dc.contributor.authorLangohr, Klaus
dc.contributor.authorCuenca Royo, Aida
dc.contributor.authorXicota, Laura
dc.contributor.authorJanel, Nathalie
dc.contributor.authorSanchez Benavides, Gonzalo
dc.contributor.authorBlehaut, Henri
dc.contributor.authordel Hoyo, Laura
dc.contributor.authorBenejam, Bessy
dc.contributor.authorBlanco Hinojo, Laura
dc.contributor.authorVidela, Sebastià
dc.contributor.authorDierssen, Mara
dc.contributor.otherUniversitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa
dc.identifier.citationDe la Torre, R., de Sola, S., Hernández, G., Farré, M., Langohr, K., Cuenca, A., Xicota, L., Janel, N., Gonzalo Sanchez-Benavides, Blehaut, H., del Hoyo, L., Benejam, B., Blanco,-Hinojo L., Videla, S., Dierssen, M. 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. "Lancet neurology", 1 Juliol 2016, vol. 15, núm. 8, p. 801-810.
dc.description.abstractBackground Early cognitive intervention is the only routine therapeutic approach used for amelioration of intellectual deficits in individuals with Down's syndrome, but its effects are limited. We hypothesised that administration of a green tea extract containing epigallocatechin-3-gallate (EGCG) would improve the effects of non-pharmacological cognitive rehabilitation in young adults with Down's syndrome.; Methods We enrolled adults (aged 16-34 years) with Down's syndrome from outpatient settings in Catalonia, Spain, with any of the Down's syndrome genetic variations (trisomy 21, partial trisomy, mosaic, or translocation) in a double-blind, placebo-controlled, phase 2, single centre trial (TESDAD). Participants were randomly assigned at the IMIM-Hospital del Mar Medical Research Institute to receive EGCG (9 mg/kg per day) or placebo and cognitive training for 12 months. We followed up participants for 6 months after treatment discontinuation. We randomly assigned participants using random-number tables and balanced allocation by sex and intellectual quotient. Participants, families, and researchers assessing the participants were masked to treatment allocation. The primary endpoint was cognitive improvement assessed by neuropsychologists with a battery of cognitive tests for episodic memory, executive function, and functional measurements. Analysis was on an intention-to-treat basis. This trial is registered with, number NCT01699711.; Findings The study was done between June 5, 2012, and June 6, 2014. 84 of 87 participants with Down's syndrome were included in the intention-to-treat analysis at 12 months (43 in the EGCG and cognitive training group and 41 in the placebo and cognitive training group). Differences between the groups were not significant on 13 of 15 tests in the TESDAD battery and eight of nine adaptive skills in the Adaptive Behavior Assessment System II (ABAS-II). At 12 months, participants treated with EGCG and cognitive training had significantly higher scores in visual recognition memory (Pattern Recognition Memory test immediate recall, adjusted mean difference: 6.23 percentage points [95% CI 0.31 to 12.14], p=0.039; d 0.4 [0.05 to 0.84]), inhibitory control (Cats and Dogs total score, adjusted mean difference: 0.48 [0.02 to 0.93], p=0.041; d 0.28 [0.19 to 0.74]; Cats and Dogs total response time, adjusted mean difference: -4.58 s [-8.54 to -0.62], p=0.024; d -0.27 [-0.72 to -0.20]), and adaptive behaviour (ABAS-II functional academics score, adjusted mean difference: 5.49 [2.13 to 8.86], p=0.002; d 0.39 [-0.06 to 0.84]). No differences were noted in adverse effects between the two treatment groups.; Interpretation EGCG and cognitive training for 12 months was significantly more effective than placebo and cognitive training at improving visual recognition memory, inhibitory control, and adaptive behaviour. Phase 3 trials with a larger population of individuals with Down's syndrome will be needed to assess and confirm the long-term efficacy of EGCG and cognitive training.; Funding Jerome Lejeune Foundation, Instituto de Salud Carlos III FEDER, MINECO, Generalitat de Catalunya.
dc.format.extent10 p.
dc.subjectÀrees temàtiques de la UPC::Matemàtiques i estadística::Probabilitat
dc.subject.lcshCombinatorial probabilities
dc.subject.otherGreen tea polyphenols
dc.subject.otherMouse models
dc.titleSafety 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
dc.contributor.groupUniversitat Politècnica de Catalunya. GRBIO - Grup de Recerca en Bioestadística i Bioinformàtica
dc.description.peerreviewedPeer Reviewed
dc.subject.amsClassificació AMS::60 Probability theory and stochastic processes::60C05 Combinatorial probability
dc.rights.accessOpen Access
dc.description.versionPostprint (author's final draft)
local.citation.authorDe la Torre, R.; de Sola, S.; Hernández, G.; Farré, M.; Langohr, K.; Cuenca, A.; Xicota, L.; Janel, N.; Sanchez-Benavides, Gonzalo; Blehaut, H.; del Hoyo, L.; Benejam, B.; Blanco, -Hinojo L.; Videla, S.; Dierssen, M.
local.citation.publicationNameLancet neurology

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