Title: Prelude DS ELND005 for Down Syndrome Information for Participants
1 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.
2What 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 peoples bodies react to the new
medicine.
3What is this study about?
- I am talking with people with Down syndrome who
are 18-45 years old. - I am asking them if they want to take part in
this study. - For this study you would visit us several times.
4Do 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 doctors notes.
5What will happen?
You will have a check-up with one of our doctors.
Dr. Skotko Dr. Schwartz
Dr. McCannon
6- My name is Mary Ellen
- I am a nurse.
- I will see you each time you come to visit us
during the study.
7What 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.
8We 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.
9You 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.
- At some visits we will do a blood test.
- And we will take a urine
- sample.
10If 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.
11- 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.