Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.

Journal Article (Clinical Trial;Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Heller, JH; Spiridigliozzi, GA; Crissman, BG; McKillop, JA; Yamamoto, H; Kishnani, PS

Published Date

  • December 2010

Published In

Volume / Issue

  • 20 / 6

Start / End Page

  • 517 - 520

PubMed ID

  • 21186971

Pubmed Central ID

  • PMC3025176

Electronic International Standard Serial Number (EISSN)

  • 1557-8992

Digital Object Identifier (DOI)

  • 10.1089/cap.2009.0099


  • eng

Conference Location

  • United States