Safety and efficacy of rivastigmine in adolescents with Down syndrome: a preliminary 20-week, open-label study.
Individuals with Down syndrome (DS) exhibit a cholinergic deficiency similar to that found in Alzheimer's disease. Cholinesterase inhibitors, used to treat Alzheimer's disease, may improve cognitive function in individuals with DS. This is the first investigation of the safety and efficacy of rivastigmine (an acetyl and butyryl cholinesterase inhibitor) on specific cognitive domains in pediatric DS. Eleven subjects with DS (ages 10-17 years) were treated with a liquid formulation of rivastigmine. Four subjects experienced no adverse events (AEs). Seven subjects reported AEs that were mild, transient and consistent with adverse events typically noted with cholinesterase inhibitors. Significant improvements were found in overall adaptive function (Vineland Adaptive Behavior Scales and Clinician's Interview-Based Impression of Change), attention (Leiter Attention Sustained tests A and B), memory (NEPSY: Narrative and Immediate Memory for Names subtests) and language (Test of Verbal Expression and Reasoning and Clinical Evaluation of Language Fundamentals-Preschool) domains. Improved language performance was found across all functional levels. These results underscore the need for larger, controlled studies employing a carefully constructed test battery capable of measuring the full scope of performance across multiple domains and a wide range of functional levels.
Heller
James H
JH
Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
Spiridigliozzi
Gail A
GA
Crissman
Blythe G
BG
Sullivan
Jennifer A
JA
Eells
Rebecca L
RL
Li
Jennifer S
JS
Doraiswamy
P Murali
PM
Krishnan
K Ranga
KR
Kishnani
Priya S
PS
D000223:Adaptation, Psychological / Q000187:drug effects; D000293:Adolescent; D001288:Attention / Q000187:drug effects; D002648:Child; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004314:Down Syndrome / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D007802:Language; D008297:Male; D008568:Memory / Q000187:drug effects; D010349:Patient Compliance; D048448:Phenylcarbamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068836:Rivastigmine; D014705:Verbal Behavior / Q000187:drug effects
D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine