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 | What is Down Syndrome?
Down syndrome is the most common form of developmental disorder. It is caused by an extra copy of chromosome 21, this is why it is sometimes referred to as Trisomy 21. This most likely occurs at conception. The presence of this extra copy alters the childs development and produces some of the physical changes that are most commonly seen with Down syndrome.
The IQ of persons with Down syndrome varies, but tends to be below average. They are able to function in school and work settings, and often lead happy healthy lives.
For additional information on Down syndrome, visit: National Down Syndrome Society website:
www.ndss.org
or
Down Syndrome Association of Minnesota:
www.dsamn.org
What treatment options are available?
There is currently no way to cure Down syndrome. There are no FDA approved treatments for Down syndrome or the cognitive delays associated with it. There are unproven theories on the use of anti-oxidants, medications for Alzheimers disease, and alternative medicine (massage, nutritional supplements, etc.) with persons with Down syndrome.
What is the purpose of this clinical trial?
The purpose of this study is to evaluate the safety and effectiveness of an investigational medication on cognitive dysfunction in children and adolescents 10-17 years old with mild-to-moderate mental retardation associated with Down syndrome. The study medication is available by prescription to treat adults with Alzheimers disease, but is not FDA approved for use in persons with Down syndrome. Therefore, the use of the study medication in children with Down syndrome is considered investigational.
How long will the study last?
In the study, 50% of participants will receive the study medication, and 50% will receive a placebo liquid (a fake or without medication). The study lasts up to 13 weeks (10 weeks of medication or placebo) and will involve 4 visits to our clinic in St. Paul.
Where is the study being conducted?
This study is taking place at approximately 35 sites around the country, including here at Regions Hospital in St. Paul, Minnesota.
How can I find out if my child is eligible to participate in the study?
You can call us at 651-739-HELP or you can complete and submit the form below. We'll contact you to provide you with more study information and to determine whether your child may be eligible to participate.
Although Regions Hospital has used reasonable precautions to safeguard the confidentiality of information received and sent over the Internet or via e-mail, Regions Hospital can not guarantee the confidentiality of such information. Individuals corresponding with us in this manner waive claims regarding any third party's access to or use of confidential information.
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