Clinical trial: "Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX) (NCT01855971)

Eligibility criteria:
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.

        Exclusion Criteria:

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? Contradiction