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Learn more about the Down Syndrome Program
Q: Why is this research study being done?
A: This is a screening study to identify adults with Down syndrome who are interested and eligible to participate in an upcoming clinical trial, which will primarily evaluate the efficacy, safety, and tolerability of the new drug. The drug holds promise in enhancing the learning, memory, and language abilities in people with Down syndrome.
Q: How long will I take part in the research study?
A: The screening protocol will require one research visit, which may take up to 5 hours. If the adult with Down syndrome is deemed eligible after the screening protocol, they will then be invited to participate in the full clinical trial, which will take place later this year. That clinical trial might take place over a month, involving weekly, or even more frequent, visits to our research center. The visits will be of varying lengths of time.
Q: What does this Screening Protocol involve?
A: Your family member with Down syndrome and one other accompanying family member will need to make one visit to MassGeneral Hospital. Dr. Skotko and the research team will collect the following information during this visit:
At the end of this visit, we will analyze the results to determine if the person with Down syndrome is eligible to continue on to the upcoming drug study.
Taking part in this screening study does not automatically guarantee that the person with Down syndrome will be able to take part in the upcoming drug study. This screening study is done to see who qualifies to participate later.
Below is an outline of who is eligible—and who is not—to participate this screening study. These criteria were established by F. Hoffman-LaRoche, the study Sponsor. The person with Down syndrome does NOT need to be an established patient in the MassGeneral Hospital Down Syndrome Program in order to participate in this research opportunity.
Please read through all of these criteria, and if you think you qualify, please call
Mary Ellen McDonough, RN, Senior Clinical Research Coordinator at the MassGeneral Hospital Down Syndrome Program at (617) 643 – 5571 or firstname.lastname@example.org. You may ask her any questions about the study.
Please remember, people will be considered on a first-come/ first-serve basis. At MassGeneral Hospital, we will have up to 33 spots for those who are interested and qualify.
Q: Why is this study on a first-come/first serve basis?
A. 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 33 subjects in this study. We are screening participants now to determine who will qualify for the drug trial early next year, and eligible patients are screened in the order in which they contact us. By screening participants now, we also have the opportunity to allow certain patients to participate if we anticipate that they will not meet any of the exclusionary criteria by the start of the drug 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:
There no restrictions for this screening protocol. However, requirements will apply to the clinical drug trial that will begin later this year. All participants must be on a stable regimen of medications (i.e., a regimen that does not change in the 4 weeks leading up to the beginning of the drug trial) and that the regimen remains unchanged for the duration of the study drug treatment. Long-term use of the following categories of medications will not be permitted during treatment with the study drug:
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