Donepezil HCl: Treating Cognitive Deficits in Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Cognitive Assessment: TMT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism Spectrum Disorder (ASD)
- •Asperger's Disorder
- •IQ of 75 or above
- •Baseline assessment tests within the acceptable range
排除标准
- •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
研究组 & 干预措施
Donepezil HCl
Donepezil HCL 5 mg and 10 mg
干预措施: Donepezil HCl (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive Assessment: TMT
时间窗: 8 weeks
TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Cognitive Assessment: EOWVT Standard Score
时间窗: 8 weeks
Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Cognitive Assessment: CVLT
时间窗: 8 weeks
California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
次要结局
未报告次要终点
研究者
Benjamin L Handen, PhD, BCBA-D
Assistant Professor of Psychiatry & Pediatric
University of Pittsburgh