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PERSEUS:Exploratory paediatric study on the use and safety of EGCG in Down syndrome sufferers. - Clinical trials with volunteers - Hospital del Mar Research Institute

Hospital del Mar Research Institute Hospital del Mar Research Institute

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PERSEUS:Exploratory paediatric study on the use and safety of EGCG in Down syndrome sufferers.

What does the study involve?

The PERSEUS paediatric clinical study is a multi-centre project aimed at assessing the safety and efficacy of a dietary preparation containing epigallocatechin gallate (EGCG) for improving cognitive performance and functionality in Down's and X-Fragile Syndrome populations.

This clinical study will allow us to corroborate the results observed in young adults with Down's Syndrome (TESTAD STUDY) using this compound, with the advantage of starting treatment at an earlier age, where the results are expected to remain more stable over time and therefore be more significant.

The hypothesis is that, despite the genetic origin of the syndromes being different, the mechanism through which EGCG provides therapeutic effects would be similar. The treatment seeks to improve the neuronal plasticity of the brain, namely the way neurones are interconnected and become increasingly straighter. These aspects are extremely important in cognitive processes such as learning and memory.

The study participants will either be treated with a nutritional supplement containing EGCG or a placebo, at random. The study will last 10 months, including the initial visits, 6 months of treatment and 3 months of follow-up to assess the stability of the treatment.

Clinical projects

Inclusion criteria

  • Children aged 6-12 with Down Syndrome or Fragile X.
  • Parents or legal guardians must give their informed consent.
  • Parents or legal guardians must be available to accompany their child to clinical visits.
  • You must have sufficient sight and hearing to be able to perform the study evaluations. Mild hearing loss is permitted.
  • Participants must be able to understand basic instructions.
Hospital del Mar Research Institute

Dr. Aiguader, 88, 08003 Barcelona
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Phone: 93 316 04 00 · Fax: 93 316 04 10