Status:
COMPLETED
"Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX)
Lead Sponsor:
Parc de Salut Mar
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 neuro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Not fulfil inclusion criteria.
- 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.
Key Trial Info
Start Date :
June 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01855971
Start Date
June 11 2013
End Date
October 31 2015
Last Update
May 10 2019
Active Locations (1)
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1
Parc de Salut MAR, Hospital del Mar Medical Research Institute-IMIM
Barcelona, Spain, 08003