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Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism Spectrum Disorders

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism

Intervention: Acetyl-Choline Esterase Inhibitors and Choline supplements (Drug); Indistinguishable placebo tablets, matching both donepezil and choline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Lidia Gabis, MD, Principal Investigator, Affiliation: Sheba Medical Center
Dorit Ben-Shalom, Ph.D, Study Director, Affiliation: Ben-Gurion University of the Negev
Shefer Shahar, Dr., Study Director, Affiliation: Sheba Medical Center
Rotem Chayu Ben-Hur, MA, Study Director, Affiliation: Sheba Medical Center

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.

Clinical Details

Official title: Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Core autistic symptoms (ATEC)

Side effects and adverse events questionnaire

Secondary outcome:

Linguistic performance (CELF-4)

Adaptive functioning (Vineland-II)

Comorbid behaviors (CSI-4 questionnaire)

Executive functions (BRIEF questionnaire)

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.

Eligibility

Minimum age: 10 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise

specified (PDD-NOS), given by a child neurologist.

- Age: 10-18 years.

- A signed parental consent form.

Exclusion criteria:

- Evidence for one of the following conditions:

- an underlying infectious disease

- chromosomal abnormality

- metabolic disorder

- specific brain related disorder (such as tuberous sclerosis)

- history of fetal cytomegalovirus infection

- birth asphyxia

- a history of major head injury

- a chronic use of non-steroidal anti-inflammatory drugs, (NSAID)

- known brain damage

- Epilepsy

- Abnormal Electro-cardiogram (ECG)

- Epileptiform EEG

- Use of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents

within the past month.

- Lack of cooperation in the screening phase

Locations and Contacts

Sheba Medical Center, Tel Hashomer, Ramat Gan 52621, Israel; Recruiting
Shahar Shefer, Dr, Phone: +972-(0)54-4381594, Email: DRShahar.Shefer@sheba.health.gov.il
Maaian Millikovsky, BA, Sub-Investigator
Additional Information

Starting date: March 2010
Last updated: July 17, 2014

Page last updated: August 23, 2015

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