Prelude DS ELND005 for Down Syndrome Information for Participants I would like to tell you what this study is about and then you can decide if you would.

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Presentation transcript:

Prelude DS ELND005 for Down Syndrome Information for Participants I would like to tell you what this study is about and then you can decide if you would like to help me. If you have questions please speak up. Your parent or caregiver can help with this.

What is a clinical trial? We give a study drug to people to find out if the study drug works and is safe. A drug company called Elan has a new medicine. We want to test how well it works. We need to know how people’s bodies react to the new medicine.

What is this study about? I am talking with people with Down syndrome who are years old. I am asking them if they want to take part in this study. For this study you would visit us several times.

Do you have to take part? You can say YES. Or you can say NO. It is okay to say NO. This will not affect your normal treatment with your doctor. If you would like to take part in the study you will have to sign a form to say that you agree. We may have to ask your doctor about you or look at your doctor’s notes.

What will happen?. Dr. Skotko Dr. Schwartz Dr. McCannon You will have a check-up with one of our doctors.

My name is Mary Ellen I am a nurse. I will see you each time you come to visit us during the study.

What else? You will have a short test done to record the rhythm of your heart. For this you will lie down for about 10 minutes and will have stickers on your body. This does not hurt. We measure your blood pressure.

We will ask your parent or caregiver some questions about you and your health. We will do some learning tests that are fun to do. And will take an x-ray picture of your lungs. This does not hurt.

At some visits we will do a blood test. And we will take a urine sample. You will have an MRI, which takes a picture of your brain. You will lay on a table while the picture is taken. The table has a doughnut shaped hole in it where you place your head. This does not hurt and will only be done once.

If all of your test results fit the requirements, you will be able to take part in the clinical trial. You will take a pill twice a day for 4 weeks. Your parent or caregiver will keep track of this. This pill may contain the study drug or no study drug (placebo). It is possible that when you take this study drug you may have dizziness, headache, sleepiness, and muscle pain. Neither you, your doctor or your caregiver will know if you are taking the pill with the medicine or the pill without the medicine.

And you will come back to visit us every couple of weeks so we can check to see how you are doing. Your parent or caregiver will come to all of your visits. You can ask questions at any time during the study and may stop taking part at any time.