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.
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Authors | Priya S Kishnani, James H Heller, Gail A Spiridigliozzi, Ira Lott, Luis Escobar, Sharon Richardson, Richard Zhang, Thomas McRae |
Journal | American 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 |
PMID | 21108390
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2010 Wiley-Liss, Inc. |
Chemical References |
- Cholinesterase Inhibitors
- Indans
- Piperidines
- Donepezil
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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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