Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01887132
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Diagnosis of an Autism Spectrum Disorder (DSM-IV diagnoses of autistic disorder or Pervasive Developmental Disorder, Not Otherwise Specified).
2. Male or Female subjects between the ages of 24 and 50 months.
3. Language scores (from the Mullen Scales of Early Learning) that are at least 1.5 SD lower than the mean.
5\. Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study.
6\. Each subject must be stable for at least 6 weeks on any medication or therapy regimen prior to entry into study and must have no newly (within 6 weeks) recognized or intolerable adverse effects from that medicine or therapy. No subjects will be asked to discontinue any medication in order to qualify for enrollment but subjects taking contraindicated drugs will not qualify for enrollment.
7\. Demonstrated REM% two standard deviations or more below the normative values for age for the randomized controlled trial part.
8\. English language is primarily spoken at home.
EXCLUSION CRITERIA:
1. Serious, unstable illnesses including gastroenterologic, respiratory, cardiovascular endocrinologic, immunologic, or hematologic disease.
2. Renal or hepatic dysfunction that would interfere with excretion or metabolism of donepezil as evidenced by increase above upper limits of normal for BUN/creatinine, or two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT) or gamma glutamate (GGT).
3. Documented history of hypersensitivity or intolerance to donepezil or other piperidine derivative.
4. Subjects must not be taking any medication known to affect REM sleep (or sleep
architecture in general) or that is contraindicated for co-administration with donepezil.
5. Presence or history of other unstable neurological disorders such as seizure disorders,
metabolic disorders, narcolepsy or movement disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
50 Months
Study:
NCT01887132
Study Brief:
Protocol Section:
NCT01887132