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February 2018

PERSEUS: New paediatric clinical trial in children with Down syndrome

The Hospital del Mar Medical Research Institute (IMIM), promotes a clinical trial in pediatric population to evaluate the safety and efficacy of a dietary preparation that contains epigallocatechin galate (EGCG) - a natural compound of green tea - in the cognitive development of children 6 to 12 with Down syndrome and will also assess its effect on children with X-Fragile syndrome.

Dr. Rafael de la Torre and Dr. Cécile Cieuta-Walti will be the principal investigators of the clinical trial.

The pediatric clinical trial will be carried out in 5 health care centers:

Hospital Niño Jesús (Madrid), Hispalense Pediatric Institute (Sevilla), Marqués de Valdecilla University Hospital (Santander), Hospital del Mar (Barcelona) and the Jérôme Lejeune Institute (Paris).
This randomized clinical trial will include 70 children with Down syndrome and X-Fragile syndrome.

The study is funded by the Fundación Mutua Madrileña and the Jérôme Lejeune Foundation, and the EGCG compound is donated by Laboratories Grand Fontaine.

The study will start in February 2018 and is expected to last for 10 months


December 2017

PHASE II, MULTICENTER, SIXTEEN-WEEK, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED EVALUATION OF THE EFFICACY, TOLERABILITY AND SAFETY OF MEMANTINE HYDROCHLORIDE ON ENHANCING THE COGNITIVE ABILITIES OF ADOLESCENTS AND YOUNG ADULTS WITH DOWN SYNDROME — study subjects wanted

A team of medical doctors and psychologists at the Case Western Reserve University, University Hospitals, and the Cleveland Clinic is investigating the effects of memantine on individuals with Down syndrome who are between the ages 15 and 32. Memantine is a medication FDA-approved for the treatment of Alzheimer's disease, but it is not approved for use in persons with Down syndrome. This study was designed to examine whether or not this medication is safe and if it can improve memory and learning skills in adolescents and young adults with Down syndrome.

This study requires the participant and his or her primary caregiver to complete five to seven outpatient visits to University Hospitals in Cleveland, Ohio. Psychological and medical tests will take place during the visits. The tests, medication, and medical care related to the study are provided free of charge. Parking will be validated, and mileage can be reimbursed for those traveling 20 miles or more to come to the study.

If you, or someone you know, would be interested and meet the following requirements:

· 15-32 years of age

· medically diagnosed with Down syndrome

· in good general health and not pregnant

· able to swallow medicine capsules (crushing of capsules will not be permitted)

· have a reliable caregiver or family member who agrees to come with the participant to all visits, provide information about the participant, and ensure compliance with the medication schedule

· know enough English to be capable of reliably completing study tests:

The study Principal Investigator is Alberto Costa, MD, PhD

Department of Pediatrics, Division of Pediatric Neurology

Case Western Reserve University and University Hospitals

For more information, please call or E-mail the study coordinator, Ms. Melissa Stasko (216-844-7281, Melissa.Stasko@case.edu)

IRB Number 06-14-41, approval date 10/18/2014


November 2017

EARLY DETECTION AND TREATMENT OF RESPIRATORY SLEEP DISORDERS IN CHILDREN WITH DOWN SYNDROME (RESPIRE 21 - Institut Jérome Lejeune)

This clinical trial, sponsored by Institut Jérôme Lejeune is an Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) detection of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years. Obstructive Sleep Apnea (OSA) is very common, underdiagnosed and therefore undertreated in children with Down syndrome (DS). OSA is associated with negative effects on behavior and neurocognitive development and contributes to intelligence deficits. Our hypothesis is that a systematic screening and an optimal correction of OSA within the first 3 years of life of DS children are associated with an improved neurocognitive development and behavior at the age of 3 years.

The primary objective is to demonstrate that an early (from 6 months of age) and systematic (every 6 months), detection of OSA by polysomnography (PSG) in children with DS during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years compared to a non-screened control group using the Griffith Mental Development Scale (GMDS) scores at the age of 3 years. Eighty (80) patients coming from 2 populations: a Study Group (40 patients) and a Standard Care Group (control group, 40 patients). Children in the Study Group will have a PSG at home every 6 months from the age of 6 months until the age of 3 years. OSA, if present, will be corrected with appropriate upper airway surgery and/or noninvasive continuous positive airway pressure (CPAP). At the age of 3 years, children will have a last PSG with a neurocognitive and behavioral evaluation. Children in the Standard Care Group will have a single PSG and a single neurocognitive and behavioral evaluation that will be used as reference for the Down Syndrome population of 3 years old and as reference for the study group. They won’t be followed prospectively and data about their medical care before 3 years of age will be collected from their medical file.

The subject main eligibility is the following:

  • Children with Down Syndrome

  • Age 6 months or less at inclusion for the Study Group and 30 to 36 months for the Standard Care Group

  • Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95)

  • Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment

  • French language spoken in child environment

This clinical trial will last 5 years including 2 years of inclusion period. Patient will be enrolled at Institute Jérôme Lejeune under supervision of Dr Isabelle Marey. This clinical trial is perfomed with the collaboration of Hôpital Necker-Enfants Malade and more specifically with the Unité de ventilation non invasive et du sommeil de l’enfant head by Pr Brigitte Fauroux.