1. Donepezil for treatment of cognitive dysfunction in children with Down syndrome aged 10-17
- Author
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Ira T. Lott, Luis F. Escobar, James H. Heller, Gail A. Spiridigliozzi, Priya S. Kishnani, Sharon Richardson, Richard Zhang, and Thomas McRae
- Subjects
Diarrhea ,Male ,Down syndrome ,medicine.medical_specialty ,Activities of daily living ,Adolescent ,Vomiting ,Neuropsychological Tests ,Placebo ,Severity of Illness Index ,law.invention ,Double-Blind Method ,Piperidines ,Randomized controlled trial ,law ,Severity of illness ,Genetics ,medicine ,Humans ,Learning ,Donepezil ,Child ,Genetics (clinical) ,Behavior ,Dose-Response Relationship, Drug ,business.industry ,Cognitive disorder ,Cognition ,Drug Tolerance ,medicine.disease ,Caregivers ,Indans ,Physical therapy ,Female ,Cholinesterase Inhibitors ,Down Syndrome ,Cognition Disorders ,business ,medicine.drug - Abstract
The objective of this 10-week, randomized, double-blind, placebo-controlled multicenter study was to assess the efficacy and safety of donepezil for the treatment of cognitive dysfunction exhibited by children with Down syndrome (DS). Intervention comprised donepezil (2.5–10 mg/day) in children (aged 10–17 years) with DS of mild-to-moderate severity. The primary measures were the Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) the sum of nine subdomain standardized scores and standard safety measures. Secondary measures included the VABS-II/PCRF scores on the following domains and their respective individual subdomains: Communication (receptive, expressive, and written); Daily Living Skills (personal, domestic, and community); Socialization (interpersonal relationships, play and leisure time, and coping skills), and scores on the Test of Verbal Expression and Reasoning, a subject-performance-based measure of expressive language. At baseline, 129 participants were assigned treatment with donepezil or placebo. During the double-blind phase, VABS II/PCRF sum of the nine subdomain standardized scores, called v-scores, improved significantly from baseline in both groups (P
- Published
- 2010