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Roche: Clinical Trial Looking at the Effects of a New Medication on Learning, Memory and Language Abilities in People with Down Syndrome
Another new clinical trial is being offered by Dr. Brian Skotko and his study team at MassGeneral Hospital. A number of spots are available to eligible adolescents and adults with Down syndrome to participate. In this clinical trial, an investigational medicine, not yet approved by the FDA, will be studied. The clinical trial is looking at how the new drug affects learning, memory, and language abilities in people with Down syndrome. There will be 180 people with Down syndrome involved in the study worldwide. We will be enrolling up to 20 participants here at MassGeneral Hospital. Currently there are spots available for ages 12-30.
This study is being funded by F. Hoffman-LaRoche, which has developed the study drug. To see if your family member is eligible to take part in this study, please review these questions first. If you would like your family member to participate in this study, or if you have further questions, please contact Mary Ellen McDonough, Senior Clinical Research Coordinator in the MassGeneral Hospital Down Syndrome Program, at 617-643-5571 or firstname.lastname@example.org.
In this study we will be examining the effect of RO5186582 in adolescents and young adults with Down syndrome. There has been limited success to date in treating cognition in people with Down syndrome and impairment in learning, memory, and speech still represent a major barrier to greater independence and accomplishment. In people with Down syndrome, the expression of a transmitter (GABA) is too high and is known to impair cognition. RO5186582 acts in the brain to prevent the expression of this transmitter. By preventing the expression of this transmitter, it is believed that memory and learning deficits can be improved.
The drug company, Roche, has made available a limited number of spots for each site participating in this study. MassGeneral Hospital has the ability to enroll up to 20 subjects in this study.
Your family member with Down syndrome must meet ALL of the following requirements to be able to participate in the drug study:
If ANY of the following apply to the person with Down syndrome at this time, he or she would NOT qualify for this study:
Medications that cannot be taken during this study:
Barbiturates (if used longer than 1 week in duration) Allobarbital, amobarbital, aprobarbital, barbexaclone, barbital, butobarbital, cyclobarbital, ethallobarbital, heptabarbital, hexobarbital, hexobarbital, metharbital, methohexital, methohexital, methylphenobarbital, pentobarbital, phenobarbital, primidone, proxibarbal, reposal, secobarbital, talbutal, thiopental, thiopental, vinbarbital, vinylbital
Benzodiazepinesand benzodiazepine-related drugs (if used longer than 1 week in duration) Adinazolam, alprazolam, bromazepam, brotizolam, camazepam, chlordiazepoxide, cinolazepam, clobazam, clonazepam, clotiazepam, cloxazolam, diazepam, doxefazepam, estazolam, eszopiclone, ethyl loflazepate, etizolam, fludiazepam, flunitrazepam, flurazepam, halazepam, haloxazolam, ketazolam, loprazolam, lorazepam, lormetazepam, medazepam, midazolam, nimetazepam, nitrazepam, nordazepam, oxazepam, oxazolam, pinazepam, potassium clorazepate, prazepam, quazepam, temazepam, tetrazepam, tofisopam, triazolam, zaleplon, zolpidem, zopiclone Other anxiolytics, hypnotics and sedatives Acetylglycinamide chloral hydrate, bromides, chloral hydrate, chloralodol, clomethiazole, dichloralphenazone, emylcamate, ethchlorvynol, mebutamate, meprobamate, methaqualone , paraldehyde
Anesthetics (except for short-term use) Alfaxalone, chloroform, desflurane, enflurane, esketamine, etomidate, halothane, isoflurane, ketamine, nitrous oxide, propofol, sevoflurane, trichloroethylene, xenon
GABAA antagonists Flumazenil
Anti-epileptic drugs Phenelzine, tiagabine, valproic acid, vigabatrin
Anti-dementia drugs Donepezil, galantamine, Ginkgo folium, memantine, rivastigmine, tacrine
Partners Human Research Committee APPROVAL Effective Date 6/6/2014
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