The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This study will test whether donepezil (Aricept(Registered Trademark)), a drug that is
approved by the Food and Drug Administration to treat Alzheimer's disease, can increase rapid
eye movement (REM) sleep in children with autism and autism spectrum disorder (ASD). Some
children with autism and ASD spend very little time in REM sleep. In some studies, decreased
REM sleep has been associated with learning and behavior problems. Donepezil can increase REM
sleep in some adults with different disorders. If it can increase REM sleep in children in
this study, it might be able to be used in future studies to see if it can help learning and
behavior problems in children with autism and ASD.
Children between 2 and 10 years of age with autism or an ASD whose percentage of REM sleep
time is well below the average for children of the same age may be eligible for this study.
Candidates are screened with a medical history, physical and neurological examinations, blood
tests, electroencephalogram (EEG) and a sleep study. The sleep study requires an overnight
stay at the NIH Clinical Center in which the child is monitored with electrodes for EEG and
heartbeat recording, a tube taped below the nose to measure airflow, a probe on a finger to
record oxygen levels and a small watch-like machine on the wrist to record movements.
Participating children may be required to have up to six overnight stays for sleep studies at
the Clinical Center. The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Then
they are admitted to the NIH Clinical Center for a sleep study, blood tests and EKG. Those
whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks,
after which they are admitted to the Clinical Center for a final physical examination, blood
draw and sleep study. That ends their participation in the study.
Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a
higher dose (2.5 mg) for 2 to 4 weeks, and the above procedure is repeated. Those whose REM
sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4
weeks, and the above procedure is repeated once more. Children whose REM sleep does not
increase to normal on 5 mg of donepezil stop the medication and end their participation in
the study.
At each study visit, study researchers talk to the parents and examine the children to
determine if donepezil is affecting the child's behavior and if the child is hav...