Prelude DS ELND005 for Down Syndrome Information for Participants - PowerPoint PPT Presentation

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Prelude DS ELND005 for Down Syndrome Information for Participants

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My name is Mary Ellen I am a nurse. ... You will have a short test done to record the rhythm of your heart. ... We measure your blood pressure. – PowerPoint PPT presentation

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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.

2
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 peoples bodies react to the new
    medicine.

3
What 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.

4
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 doctors notes.

5
What 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.

7
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.

8
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.

9
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.
  • At some visits we will do a blood test.
  • And we will take a urine
  • sample.

10
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.

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.
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