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Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool | Clinical Trials | Clareo Health

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Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool

NCT01699711•Parc de Salut Mar

View on ClinicalTrials.gov

Summary

Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.

Eligibility

Age

14 - 29 years

Sex

ALL

Healthy Volunteers

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 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.

Locations (1)

IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)

Barcelona, Barcelona, Spain

Key Dates

Start Date

February 1, 2012

Primary Completion Date

June 1, 2014

Completion Date

March 1, 2015

Last Updated

February 11, 2016

Enrollment

ACTUAL participants

Conditions

Down Syndrome (DS)

Interventions

Epigallocatechin-3-gallate (EGCG)

DIETARY_SUPPLEMENT

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool

Inclusion Criteria

Exclusion Criteria

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities

Awareness of Families With Down Syndrome Children About the Role of Physical Therapy in Egypt