"Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-11

Study Completion Date

2015-10-31

Brief Summary

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Fragile X syndrome (FXS) presents alterations in synaptic plasticity that produce intellectual disability. can produce improvement. Estrogens (targeting Estrogen Receptors beta (ER-β) can act as neuroprotective agents, promoting synaptic plasticity and neurite outgrowth, and health benefits derived from flavonoids, as the flavonol epigallocatechin gallate (EGCG), phytoestrogens of natural origin are partially explained by their interaction with membrane ER. Selective ER-β flavonoids are thus good candidates for their therapeutic evaluation in intellectual disabilities. EGCG also targets central intracellular transduction signals altered in FXS and improves memory recognition in a FXS animal model(adenosine triphosphate (ATP)-inhibitor of phosphatidylinositol 3-kinase (PI3K)and mammalian target of rapamycin (mTOR) and extracellular signal-regulated kinase (ERK1/2). This study targets the synaptic plasticity alterations that underlie the learning and memory impairment but also the computational disability in FXS. The hypothesis is that EGCG can act by favoring the physiological processes involved in cognition.

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Detailed Description

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Conditions

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Fragile X Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study lasts 7 months :

* from day 0 to month 1, patients will receive placebo, in order to avoid the placebo effect of the treatment.
* from month 1 to month 4 : patients will be divided in two cohorts, one group receiving ECGC (experimental group), and the other placebo (control group).
* from mont 4 to month 7 : no treatment in given, only effects of cessation of treatment are observed.

Patients from both arms will receive Cognitive training.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Placebo medication consists in rice flour tablets, given to patients of control group with the same posology than the ones of the experimental group (2\*200mg / day).

Study Groups

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Fragile X syndrome experimental group

1. Administration of 400 mg/day of epigallocatechin-3-gallate (EGCG). Life Extension, Mega Green Tea Extract Decaffeinated, a dietary supplement containing EGCG extract (45% EGCGC).

Dosage form: capsules of 200mg Route of administration: orally Dosage: 2 capsules per day (400 mg EGCG/day) Frequency: one capsule in the morning (fasting state) and a second capsule in the afternoon (before dinner).

Treatment period: 3 months (from month 1 to month 4)
2. Cognitive training: non-pharmacological cognitive training 3 sessions per week (1 hour per session) by using the Feskits program.

Group Type ACTIVE_COMPARATOR

EGCG

Intervention Type DIETARY_SUPPLEMENT

Life Extension, Mega Green Tea Extract Decaffeinated is a dietary supplement containing EGCG extract (45% EGCG). This extract contains 98% total polyphenols and 45% epigallocatechin-3-gallate (EGCG). EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.

Cognitive training

Intervention Type OTHER

Feskits program 3 times per week (1 hour/session) Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention, attention/perception, working memory, auditory and visual memory, executive function and language.

Fragile X syndrome control group

1. Placebo administration. Placebo consists in capsules containing rice flour. Dosage form: capsules Route of administration: orally Dosage: 2 capsules per day Frequency: one capsule in the morning (fasting state) and a second capsule in the afternoon (before dinner).
2. Cognitive training: non-pharmacological cognitive training 3 sessions per week (1 hour per session) by using the Feskits program.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Same capsules containing rice flour. No active treatment is given.

Cognitive training

Intervention Type OTHER

Feskits program 3 times per week (1 hour/session) Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention, attention/perception, working memory, auditory and visual memory, executive function and language.

Interventions

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EGCG

Life Extension, Mega Green Tea Extract Decaffeinated is a dietary supplement containing EGCG extract (45% EGCG). This extract contains 98% total polyphenols and 45% epigallocatechin-3-gallate (EGCG). EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Same capsules containing rice flour. No active treatment is given.

Intervention Type DIETARY_SUPPLEMENT

Cognitive training

Feskits program 3 times per week (1 hour/session) Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention, attention/perception, working memory, auditory and visual memory, executive function and language.

Intervention Type OTHER

Other Intervention Names

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Epigallocatechin-3-gallate (EGCG) Matched placebo

Eligibility Criteria

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Inclusion Criteria

* Molecular diagnosis of Fragile X syndrome (FXS)
* Males and females aged 12 to 60 years.
* Study participants must understand and accept experimental procedures and assent to participate in the study signing an informed consent.
* Parents or caregivers have to understand and accept experimental procedures and sign informed consent form.
* Use of effective contraceptive methods in female participants
* Regular menstrual cycle (26-32 days duration) in female subjects
* Moderate mental disability (IQ\>40)
* Body mass index (BMI) comprised between 18.5 and 29.9 kg/m2, and body weight between 50 and 100 kg.
* Non-smokers
* Electroencephalogram record and general blood and urine analysis performed at screening visit should be within normal values. Minor or occasional variations in normal values are allowed if, in the opinion of Principal Investigator, taking into account the state of the science, they are not clinically significant, they do not pose risk for the subjects and they do not interfere in the evaluation of the investigational product. These variations and their non-relevance should be justified by writing.

* Subjects with neurological disease other than FXS, 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 12 months preceding the study.
* Regular ingestion of psychotropic drugs in the three months 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 non steroidal antiinflammatory drug (NSAID) in the two weeks preceding the study.
* History or clinical proof 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 cognitive training.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No