Donepezil HCl & Cognitive Deficits in Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Donepezil HCl: Treating Cognitive Deficits in Autism

Conditions
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Autistic Disorder

Intervention / Treatment
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* Drug: Donepezil HCl
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil HCl<br>Donepezil HCL 5 mg and 10 mg | Drug: Donepezil HCl<br>* Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.<br>* Other names: Aricept;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo used in placed of Donepezil HCL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Assessment: TMT | TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better | 8 weeks | 
| Cognitive Assessment: EOWVT Standard Score | Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better | 8 weeks | 
| Cognitive Assessment: CVLT | California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better | 8 weeks |