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

Publication ,  Journal Article
Heller, JH; Spiridigliozzi, GA; Crissman, BG; McKillop, JA; Yamamoto, H; Kishnani, PS
Published in: J Child Adolesc Psychopharmacol
December 2010

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.

Duke Scholars

Published In

J Child Adolesc Psychopharmacol

DOI

EISSN

1557-8992

Publication Date

December 2010

Volume

20

Issue

6

Start / End Page

517 / 520

Location

United States

Related Subject Headings

  • Time Factors
  • Rivastigmine
  • Phenylcarbamates
  • Neuroprotective Agents
  • Male
  • Language Tests
  • Language Disorders
  • Humans
  • Follow-Up Studies
  • Down Syndrome
 

Citation

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ICMJE
MLA
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Heller, J. H., Spiridigliozzi, G. A., Crissman, B. G., McKillop, J. A., Yamamoto, H., & Kishnani, P. S. (2010). Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up. J Child Adolesc Psychopharmacol, 20(6), 517–520. https://doi.org/10.1089/cap.2009.0099
Heller, James H., Gail A. Spiridigliozzi, Blythe G. Crissman, Jane Anne McKillop, Haru Yamamoto, and Priya S. Kishnani. “Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.J Child Adolesc Psychopharmacol 20, no. 6 (December 2010): 517–20. https://doi.org/10.1089/cap.2009.0099.
Heller JH, Spiridigliozzi GA, Crissman BG, McKillop JA, Yamamoto H, Kishnani PS. Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):517–20.
Heller, James H., et al. “Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.J Child Adolesc Psychopharmacol, vol. 20, no. 6, Dec. 2010, pp. 517–20. Pubmed, doi:10.1089/cap.2009.0099.
Heller JH, Spiridigliozzi GA, Crissman BG, McKillop JA, Yamamoto H, Kishnani PS. Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):517–520.
Journal cover image

Published In

J Child Adolesc Psychopharmacol

DOI

EISSN

1557-8992

Publication Date

December 2010

Volume

20

Issue

6

Start / End Page

517 / 520

Location

United States

Related Subject Headings

  • Time Factors
  • Rivastigmine
  • Phenylcarbamates
  • Neuroprotective Agents
  • Male
  • Language Tests
  • Language Disorders
  • Humans
  • Follow-Up Studies
  • Down Syndrome