Donepezil HCl & Cognitive Deficits in Autism

Donepezil HCl: Treating Cognitive Deficits in Autism

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.

Study Overview

• Status: Completed
• Conditions: Autistic Disorder
• Intervention / Treatment: Drug: Donepezil HCl; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Western Psychiatric Institute & Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo used in placed of Donepezil HCL
Experimental: Donepezil HCl; Donepezil HCL 5 mg and 10 mg	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.; Other Names: Aricept

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Benjamin L. Handen, PhD, University of Pittsburgh, School of Medicine, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: October 11, 2002
• First Submitted That Met QC Criteria: October 15, 2002
• First Posted (Estimate): October 16, 2002

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Cognitive Dysfunction; Autistic Disorder; Cognition Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: R21MH064941 (U.S. NIH Grant/Contract); DSIR CT-M3 (Other Identifier: NIMH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We have no specific plan to share data at this time.