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<p>Prenatal alcohol exposure impacts fetal development, leading to Fetal Alcohol Spectrum Disorders (FASD) characterized by cognitive, behavioral, and physical impairments. This pre-post, open-label, non-randomized pilot study explores Epigallocatechin-3-Gallate (EGCG), a potent antioxidant and neuronal plasticity modulator, as a therapeutic intervention for FASD improvement. In a 12-month pilot study, patients with 40 FASD (mean age 10 ± 3 years) received 9&#xa0;mg/kg/day of EGCG, with outcomes assessed through RNA sequencing and neurocognitive evaluations (WISC-IV, CBCL 6–18, and NEPSY-II). Reduced levels of oxidative stress were observed after 6 and 12 months of treatment with EGCG. Significant neurocognitive improvements were shown after one year of treatment in Perceptual Reasoning Index (PRI) and Working Memory Index (WMI) using the WISC-IV test. CBCL test revealed an improvement in aggressive behavior scores after EGCG treatment. NEPSY-II assessment showed improvements in face memory and delayed face memory. Interestingly, no significant improvements were observed in intelligence quotient, attention, anxiety, or depression, which affect a proportion of individuals diagnosed with FASD. Additionally, EGCG modulates molecular pathways associated with neuroinflammation, immune response, and neurogenesis. This study highlights EGCG as a potential therapeutic candidate to ameliorate cognitive and behavioral deficits in children affected by FASD, revealing potential pathways and biomarkers that contribute to these improvements.</p><p><i>ClinicalTrials.gov identifier:&#xa0;</i>NCT02558933 (registered 22 September 2015).</p>

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Cognitive and transcriptomic effects of Epigallocatechin gallate in fetal alcohol spectrum disorders

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月2日

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  • Anna Ramos-Triguero,
  • Marta Astals-Vizcaino,
  • Elisabet Navarro-Tapia,
  • Melina Vieiros,
  • Adriana Bastons-Compta,
  • Leopoldo Martínez,
  • Vicente Andreu-Fernández,
  • Óscar García-Algar

摘要

Prenatal alcohol exposure impacts fetal development, leading to Fetal Alcohol Spectrum Disorders (FASD) characterized by cognitive, behavioral, and physical impairments. This pre-post, open-label, non-randomized pilot study explores Epigallocatechin-3-Gallate (EGCG), a potent antioxidant and neuronal plasticity modulator, as a therapeutic intervention for FASD improvement. In a 12-month pilot study, patients with 40 FASD (mean age 10 ± 3 years) received 9 mg/kg/day of EGCG, with outcomes assessed through RNA sequencing and neurocognitive evaluations (WISC-IV, CBCL 6–18, and NEPSY-II). Reduced levels of oxidative stress were observed after 6 and 12 months of treatment with EGCG. Significant neurocognitive improvements were shown after one year of treatment in Perceptual Reasoning Index (PRI) and Working Memory Index (WMI) using the WISC-IV test. CBCL test revealed an improvement in aggressive behavior scores after EGCG treatment. NEPSY-II assessment showed improvements in face memory and delayed face memory. Interestingly, no significant improvements were observed in intelligence quotient, attention, anxiety, or depression, which affect a proportion of individuals diagnosed with FASD. Additionally, EGCG modulates molecular pathways associated with neuroinflammation, immune response, and neurogenesis. This study highlights EGCG as a potential therapeutic candidate to ameliorate cognitive and behavioral deficits in children affected by FASD, revealing potential pathways and biomarkers that contribute to these improvements.

ClinicalTrials.gov identifier: NCT02558933 (registered 22 September 2015).