Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047697
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2002-10-11
Brief Title:
Donepezil HCl Cognitive Deficits in Autism
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Donepezil HCl Treating Cognitive Deficits in Autism
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 11-week study will examine the safety and effectiveness of the medication donepezil Aricept compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder
Detailed Description:
Children with autism spectrum disorder ASD often have impaired communication problems with social interaction and repetitive and stereotyped patterns of behavior While most research has attempted to treat the behavioral deficits commonly associated with ASD few studies have attempted to improve the core features of this disorder A recent study found that donepezil HCl helped to improve speech production attention span and ability to express emotions in a group of children with autism This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD
This study begins at Week 1 with a baseline assessment Participants are then randomly assigned to either donepezil HCl or placebo Participants will start with either a 5mgday dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose Participants will then have their dose increased to 10mgday Another cognitive assessment will be given after 4 weeks on this dose
This study begins at Week 1 with a baseline assessment Participants are then randomly assigned to either donepezil HCl or placebo Participants will start with either a 5mgday dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose Participants will then have their dose increased to 10mgday Another cognitive assessment will be given after 4 weeks on this dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-M3 | OTHER | NIMH | httpsreporternihgovquickSearchR21MH064941 |
| R21MH064941 | NIH | None | None |