Donepezil HCl & Cognitive Deficits in Autism

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH); University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Autism Spectrum Disorder (ASD)

• Asperger's Disorder

• IQ of 75 or above

• Baseline assessment tests within the acceptable range

Exclusion Criteria:

• Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder

• Seizure disorder requiring the use of anticonvulsant medications

• Congenital rubella, cytomegalovirus, or tuberous sclerosis

• Certain medications prescribed for management of behavior (please contact the investigator for a complete list)

• Medications/preparations that are known to interact with donepezil HCl

• Significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition

• Pregnancy or sexually active females not using a reliable method of contraception