Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02558933
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Organization:
Study Overview
Official Title:
Epigallocatechin Gallate (EGCG) as Therapeutic Tool to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neuro-SAF
Brief Summary:
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.
The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Detailed Description:
Background
1% of children present a prenatal alcohol exposure related disorder. Prevalence of consumption increases every year. In a previous study in Barcelona, 45.5% of ethanol positive meconiums were detected, as a biomarker of maternal consumption of alcohol during pregnancy. The most serious clinical picture including facial, mental and cognitive disorders is Foetal Alcohol Syndrome (FAS). Spain is the second country in adoptions from East Europe, where the consumption of alcohol during pregnancy is most important. The only prevention of FAS is avoiding consumption of alcohol during pregnancy and there is no treatment for its deleterious effects on neurodevelopment.
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.
Objective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Methodology Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 5 and 16 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Instrumentalization
1. Cognitive and neuropsychologic diagnostic scales of FAS
2. Determination of values of oxidative stress
3. Determination of control biomarkers of the treatment
1% of children present a prenatal alcohol exposure related disorder. Prevalence of consumption increases every year. In a previous study in Barcelona, 45.5% of ethanol positive meconiums were detected, as a biomarker of maternal consumption of alcohol during pregnancy. The most serious clinical picture including facial, mental and cognitive disorders is Foetal Alcohol Syndrome (FAS). Spain is the second country in adoptions from East Europe, where the consumption of alcohol during pregnancy is most important. The only prevention of FAS is avoiding consumption of alcohol during pregnancy and there is no treatment for its deleterious effects on neurodevelopment.
The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome.
Objective To determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients.
Methodology Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 5 and 16 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with three clinical assessments (at baseline, 6 months, and 12 months) during the treatment period.
Instrumentalization
1. Cognitive and neuropsychologic diagnostic scales of FAS
2. Determination of values of oxidative stress
3. Determination of control biomarkers of the treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: