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NCT00695136 · ClinicalTrials.gov registry record · Phase 1
The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00695136 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 17 participants.
The verdict
NCT00695136, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study 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 ab
Interventions
- DRUG Donepezil hydrochloride
- BEHAVIORAL Increase REM sleep percentage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00695136
The ClinicalTrials.gov registry entry for NCT00695136 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Donepezil hydrochloride is the first listed.
NCT00695136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00695136 about?
NCT00695136 is a clinical study titled "The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism". 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 ...
What is the current status of trial NCT00695136?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2008-06. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00695136?
The interventions under investigation include: Donepezil hydrochloride (DRUG), Increase REM sleep percentage (BEHAVIORAL).
Who is sponsoring clinical trial NCT00695136?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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