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| ID | Type | Description | Link |
|---|---|---|---|
| R21MH064941 | U.S. NIH Grant/Contract | View source | |
| DSIR CT-M3 | Other Identifier | NIMH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil HCl | Experimental | Donepezil HCL 5 mg and 10 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil HCl | Drug | Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin L. Handen, PhD | University of Pittsburgh, School of Medicine, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute & Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
We have no specific plan to share data at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil HCL | Subjects placed on 5 and 10 mg of donepezil |
| FG001 | Placebo | Subjects placed on 5 mg or 10 mg of placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil HCL | 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. |
| BG001 | Placebo | Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cognitive Assessment: TMT | TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better | Posted | Mean | Standard Deviation | seconds | 8 weeks |
|
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AEs were collected for 10 weeks (and for longer if a subject had an active AE at the end of the 10-week trial).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil HCL | 5 mg of donepezil for 4 weeks, followed by 10 mg of donepezil for 6 weeks. |
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The trial may not have been long enough to obtain clinically significant effects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin L. Handen, PhD | University of Pittsburgh | 412-235-5445 | handenbl@upmc.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Placebo used in placed of Donepezil HCL |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Cognitive Assessment: TMT | TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better | Mean | Standard Deviation | Seconds |
|
| Cognitive Assessment: EOWVT Standard score | Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better | Mean | Standard Deviation | units on a scale |
|
| Cognitive Assessment: CVLT | California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better | Mean | Standard Deviation | Correct answers, percentage |
|
| Participants |
|
|
| Primary | Cognitive Assessment: EOWVT Standard Score | Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Primary | Cognitive Assessment: CVLT | California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better | Posted | Mean | Standard Deviation | percentage of correct answers | 8 weeks |
|
|
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Placebo substituted for Donepezil HCL | 0 | 16 | 0 | 16 | 0 | 16 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |