Donepezil HCl & Cognitive Deficits in Autism

Autistic Disorder Clinical Trial

Official title: Donepezil HCl: Treating Cognitive Deficits in Autism

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autistic Disorder
• Cognition Disorders

• NCT number: NCT00047697
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 2
• Start date: October 2002
• Completion date: August 2006