Donepezil HCl & Cognitive Deficits in Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047697
Recruitment Status : Completed
First Posted : October 16, 2002
Results First Posted : October 5, 2017
Last Update Posted : October 5, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

October 11, 2002
October 16, 2002
March 30, 2015
October 5, 2017
October 5, 2017
October 2002
August 2006   (Final data collection date for primary outcome measure)
  • Cognitive Assessment: TMT [ Time Frame: 8 weeks ]
    TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
  • Cognitive Assessment: EOWVT Standard Score [ Time Frame: 8 weeks ]
    Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
  • Cognitive Assessment: CVLT [ Time Frame: 8 weeks ]
    California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
Not Provided
Complete list of historical versions of study NCT00047697 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • 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 Name: Aricept
  • Drug: Placebo
    Placebo used in placed of Donepezil HCL
  • Experimental: Donepezil HCl
    Donepezil HCL 5 mg and 10 mg
    Intervention: Drug: Donepezil HCl
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
R21MH064941( U.S. NIH Grant/Contract )
R21MH064941 ( U.S. NIH Grant/Contract )
DSIR CT-M3 ( Other Identifier: NIMH )
Not Provided
Plan to Share IPD: No
Plan Description: We have no specific plan to share data at this time.
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Benjamin L. Handen, PhD University of Pittsburgh, School of Medicine, Department of Psychiatry
University of Pittsburgh
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP