Donepezil HCl & Cognitive Deficits in Autism

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.

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