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