title: Safety and efficacy of rivastigmine in adolescents with Down syndrome: a preliminary 20-week, open-label study.
abstract: 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.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: James H
authors.initials: JH
authors.lastname: Heller
authors.forename: Gail A
authors.initials: GA
authors.lastname: Spiridigliozzi
authors.forename: Blythe G
authors.initials: BG
authors.lastname: Crissman
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Sullivan
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Eells
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Li
authors.forename: P Murali
authors.initials: PM
authors.lastname: Doraiswamy
authors.forename: K Ranga
authors.initials: KR
authors.lastname: Krishnan
authors.forename: Priya S
authors.initials: PS
authors.lastname: Kishnani
mesh_terms: 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
chemical_list: D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine