Phase 2
Completed N=34
Donepezil HCl & Cognitive Deficits in Autism
Autistic Disorder
Source: ClinicalTrials.gov NCT00047697 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Cognitive Assessment: TMT — 118.3; 104.7 seconds
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Assessment: TMT |
118.3; 104.7 | — |
| PRIMARY Cognitive Assessment: EOWVT Standard Score |
109.7; 114.5 | — |
| PRIMARY Cognitive Assessment: CVLT |
50.2; 51.3 | — |
Eligibility Criteria
Inclusion Criteria
- Autism Spectrum Disorder (ASD)
- Asperger's Disorder
- IQ of 75 or above
- Baseline assessment tests within the acceptable range
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00047697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.