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Donepezil for treatment of cognitive dysfunction in children with Down syndrome aged 10-17.

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 < 0.0001), with no significant between-group differences. This trial failed to demonstrate any benefit for donepezil versus placebo in children and adolescents with DS, although donepezil appeared to be well tolerated.
AuthorsPriya S Kishnani, James H Heller, Gail A Spiridigliozzi, Ira Lott, Luis Escobar, Sharon Richardson, Richard Zhang, Thomas McRae
JournalAmerican journal of medical genetics. Part A (Am J Med Genet A) Vol. 152A Issue 12 Pg. 3028-35 (Dec 2010) ISSN: 1552-4833 [Electronic] United States
PMID21108390 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2010 Wiley-Liss, Inc.
Chemical References
  • Cholinesterase Inhibitors
  • Indans
  • Piperidines
  • Donepezil
Topics
  • Adolescent
  • Behavior (drug effects)
  • Caregivers (psychology)
  • Child
  • Cholinesterase Inhibitors (adverse effects, pharmacology, therapeutic use)
  • Cognition Disorders (drug therapy, physiopathology)
  • Diarrhea (chemically induced)
  • Donepezil
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Down Syndrome (drug therapy, physiopathology)
  • Drug Tolerance
  • Female
  • Humans
  • Indans (adverse effects, pharmacology, therapeutic use)
  • Learning (drug effects)
  • Male
  • Neuropsychological Tests
  • Piperidines (adverse effects, pharmacology, therapeutic use)
  • Severity of Illness Index
  • Vomiting (chemically induced)

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