NCT00047697

Donepezil HCl & Cognitive Deficits in Autism

Donepezil HCl: Treating Cognitive Deficits in Autism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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 5mg/day 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 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Donepezil HCl	Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
DRUG	Placebo	Placebo used in placed of Donepezil HCL

Timeline

• Start date: 2002-10-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2002-10-16
• Last updated: 2017-10-05
• Results posted: 2017-10-05

Locations

1 site across 1 country: United States