Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism
Overview
- Phase
- Phase 4
- Intervention
- Indistinguishable placebo tablets, matching both donepezil and choline
- Conditions
- Autism
- Sponsor
- Sheba Medical Center
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Side effects and adverse events questionnaire
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr. Lidia Gabis MD
Dr. Lidia Gabis
Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo for AChEI and Choline
Intervention: Indistinguishable placebo tablets, matching both donepezil and choline
AChEI and Choline
Acetyl-choline Esterase Inhibitor and Choline supplements
Intervention: Acetyl-Choline Esterase Inhibitors and Choline supplements
Outcomes
Primary Outcomes
Side effects and adverse events questionnaire
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)