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This study examined EGCG (Epigallocatechin-3-gallate), a compound that blocks the DYRK1A enzyme, compared with placebo for its effect on cognitive function in people with Down syndrome. It enrolled individuals aged 14 to 29 diagnosed with Down syndrome. It was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody). Exclusion Criteria: * Subjects with neurological disease other than DS, relevant medical disease, co-morbid mental disorder or currently taking any treatment that could interfere with cognitive function or alter any key biomarkers and biochemical parameters analyzed. * Having suffered from any major illness or undergoing major surgery in the last three months before the study; * Regular ingestion of medication in the month preceding the study. Exceptions were made for single doses of symptomatic medication administered up to the week preceding the trial. * Current ingestion of vitamin supplements or catechins or AINE in the two weeks preceding the study. * History of gastrointestinal, hepatic or renal problems or any other cause that may alter processes of absorption, distribution, metabolism, or excretion of the drug, or that might suggest gastrointestinal irritation to drug. * Subjects following a vegetarian diet. * Practice of physical exercise for more than 2 hours per day or energy consume/consumption of more than 3000 kcal per week.