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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Collaborator: The Israeli Society of Clinical Pediatrics (HIPAK)
• Treatments: Acetylcholine; Choline; Donepezil

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