Clinical Trial TitleA multicenter, randomized, double-blind, placebo-controlled, multiple dose study to investigate safety and tolerability of RO5186582 in individuals with Down syndrome (Study BP25543).
Clinical Trial Protocol Description:
People with Down syndrome can have cognitive problems. Some of these problems include lower-than-average learning, memory and language ability. One of the goals of this study is to find out whether RO5186582 is safe and effective for treating some of these Down syndrome symptoms. Information from this study will also be used to help find a diagnostic test to identify patients with Down syndrome who may be treated better with RO5186582. About 33 study subjects with Down syndrome will participate in this study at about 10 centers. The centers will be located in the United Kingdom and United States. It is anticipated that up to seven subjects with Down syndrome will participate in this study at Rush University Medical Center.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are between 18 and 30 years of age and have Down syndrome (confirmed by karyotype). Subjects may have standard trisomy 21 or complete unbalanced translocation of the chromosome 21.
You will be excluded from the study if any of the following criteria apply to you:
- Have mosaic Down syndrome.
- Are pregnant or plan to become pregnant during the trial.
This is a partial list of eligibility requirements.