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临床试验/NCT01098383
NCT01098383Unknown4 期

Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
84
试验地点
1
主要终点
Side effects and adverse events questionnaire

研究概览

简要总结

We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.

详细描述

Autism Spectrum Disorders (ASD) are a group of developmental disorders of brain function resulting in a distinct phenotype, most probably related to many specific causes. Individuals with a disorder in the autism spectrum are a heterogeneous group of patients with early childhood onset of deficits in social interaction, communication and language, and repetitive and stereotypic behaviors. ASD has become increasingly prevalent during the last few decades (Wiznitzer, 2005).

The neuro-anatomical substrate of ASD has been the subject of intense investigation, but current findings are inconclusive, limited and sometimes even contradictory.

Medical treatment of autism is still a matter of dispute. Medications used are mainly aimed to treat the comorbid symptoms, such as epilepsy, tics, obsessive-compulsive or hyperactive behaviors (Wiznitzer, 2005). Although many efforts were invested in establishing a model of autistic pathophysiology, no such model is currently accepted, and there is no evidence for an efficient treatment of the core autistic symptoms (Wiznitzer, 2005).

Previous studies indicate that many brain systems are involved in the expression of autism. Specifically, it has been suggested that autism involves neurotransmitter dysregulations (Lam et al, 2006). A recent investigation of the cholinergic system in autism, detailed below, has provided promising findings. Our study aims to assess the clinical outcomes associated with cholinergic manipulations using pharmacological agents and nutritional supplements. The study approved by the Helsinki committee for clinical research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo for AChEI and Choline

Placebo Comparator

干预措施: Indistinguishable placebo tablets, matching both donepezil and choline (Drug)

AChEI and Choline

Experimental

Acetyl-choline Esterase Inhibitor and Choline supplements

干预措施: Acetyl-Choline Esterase Inhibitors and Choline supplements (Drug)

结局指标

主要结局

Side effects and adverse events questionnaire

时间窗: Once every 4 weeks during the first phase(12 weeks)

A detailed parent questionnaire to assess side effects and adverse events. The parents will fill out these questionnaires about their child once every 4 weeks during the first phase(12 weeks)- which is the treatment phase.

Core autistic symptoms (ATEC)

时间窗: Once every 4 weeks during the first three mounth

The parents will fill out this questionnaire about their child once every 4 weeks during the first Phase (12 weeks)- the Treatment phase.

次要结局

  • Linguistic performance (CELF-4)(After 6 mounth of washout)
  • Comorbid behaviors (CSI-4 questionnaire)(After 6 mouth of washout)
  • Executive functions (BRIEF questionnaire)(After 6 mounth of washout)
  • Adaptive functioning (Vineland-II)(After 6 mounth of washout)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Lidia Gabis MD

Dr. Lidia Gabis

Sheba Medical Center

研究点 (1)

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