Show simple item record Heller, JH Spiridigliozzi, GA Crissman, BG McKillop, JA Yamamoto, H Kishnani, PS
dc.coverage.spatial United States 2011-04-15T16:46:26Z 2010-12
dc.identifier.citation J Child Adolesc Psychopharmacol, 2010, 20 (6), pp. 517 - 520
dc.description.abstract Following the completion of a 20-week, open-label study of the safety and efficacy of liquid rivastigmine for adolescents with Down syndrome, 5 of the 10 adolescents in the clinical trial continued long-term rivastigmine therapy and 5 did not. After an average period of 38 months, all 10 subjects returned for a follow-up assessment to determine the safety and efficacy of long-term rivastigmine use. Rivastigmine was well tolerated and overall health appeared to be unaffected by long-term rivastigmine use. Performance change on cognitive and language measures administered at the termination of the open-label clinical trial was compared between the two groups. No between-group difference in median performance change across the long-term period was found, suggesting that the long-term use of rivastigmine does not improve cognitive and language performance. However, two subjects demonstrated remarkable improvement in adaptive function over the long-term period. Both subjects had received long-term rivastigmine therapy. The discussion addresses the challenge of assessing cognitive change in clinical trials using adolescents with Down syndrome as subjects and the use of group versus individual data to evaluate the relevance of medication effects.
dc.format.extent 517 - 520
dc.language eng
dc.language.iso en_US en_US
dc.relation.ispartof J Child Adolesc Psychopharmacol
dc.relation.isversionof 10.1089/cap.2009.0099
dc.subject Adolescent
dc.subject Cognition
dc.subject Down Syndrome
dc.subject Follow-Up Studies
dc.subject Humans
dc.subject Language Disorders
dc.subject Language Tests
dc.subject Male
dc.subject Neuroprotective Agents
dc.subject Phenylcarbamates
dc.subject Rivastigmine
dc.subject Time Factors
dc.title Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.
dc.type Journal Article
dc.description.version Version of Record en_US 2010-12-0 en_US
duke.description.endpage 520 en_US
duke.description.issue 6 en_US
duke.description.startpage 517 en_US
duke.description.volume 20 en_US
dc.relation.journal Journal of child and adolescent psychopharmacology en_US
pubs.issue 6
pubs.organisational-group /Duke
pubs.organisational-group /Duke/School of Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Pediatrics
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Pediatrics/Pediatrics, Medical Genetics
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Psychiatry & Behavioral Sciences
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Psychiatry & Behavioral Sciences/Psychiatry, Child & Family Mental Health and Developmental Neuroscience
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers/Duke Clinical Research Institute
pubs.publication-status Published
pubs.volume 20
dc.identifier.eissn 1557-8992

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