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Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series.

Publication ,  Journal Article
Spiridigliozzi, GA; Heller, JH; Crissman, BG; Sullivan-Saarela, JA; Eells, R; Dawson, D; Li, J; Kishnani, PS
Published in: Am J Med Genet A
July 1, 2007

There is growing evidence to support the use of early central cholinergic enhancement to improve cognitive functioning in individuals with Down syndrome (DS). This report summarizes preliminary safety and cognitive efficacy data for seven children (8-13 years) with DS who participated in a 22-week, open-label trial of donepezil hydrochloride. Donepezil was dosed once daily at 2.5 mg and, based on tolerability, increased to 5 mg/day. Safety assessments were conducted at Week 1 (baseline), Week 8 (2.5 mg donepezil), Week 16 (5 mg) and Week 22 (after the donepezil had been discontinued). Measures of cognitive function were administered at each visit, encompassing the following domains: memory; attention; mood; and adaptive functioning. Donepezil was well tolerated at the 2.5 and 5 mg doses. The side effects were mild, transient, and consistent with the adverse events noted with cholinesterase inhibitors. Some children showed improvement on measures of memory (NEPSY Memory for Names and Narrative Memory) and sustained attention to tasks (Conners' Parent Rating Scales), although increased irritability and/or assertiveness were noted in some patients. Overall, this clinical report series adds to our initial findings of language gains in children with DS treated with donepezil. It also supports the need for larger, double-blind studies of the safety and efficacy of donepezil and other cholinesterase inhibitors for children with DS.

Duke Scholars

Published In

Am J Med Genet A

DOI

ISSN

1552-4825

Publication Date

July 1, 2007

Volume

143A

Issue

13

Start / End Page

1408 / 1413

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Piperidines
  • Male
  • Indans
  • Humans
  • Female
  • Drug Administration Schedule
  • Down Syndrome
  • Donepezil
  • Cognition
 

Citation

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Spiridigliozzi, G. A., Heller, J. H., Crissman, B. G., Sullivan-Saarela, J. A., Eells, R., Dawson, D., … Kishnani, P. S. (2007). Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series. Am J Med Genet A, 143A(13), 1408–1413. https://doi.org/10.1002/ajmg.a.31790
Spiridigliozzi, Gail A., James H. Heller, Blythe G. Crissman, Jennifer A. Sullivan-Saarela, Rebecca Eells, Deborah Dawson, Jennifer Li, and Priya S. Kishnani. “Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series.Am J Med Genet A 143A, no. 13 (July 1, 2007): 1408–13. https://doi.org/10.1002/ajmg.a.31790.
Spiridigliozzi GA, Heller JH, Crissman BG, Sullivan-Saarela JA, Eells R, Dawson D, et al. Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series. Am J Med Genet A. 2007 Jul 1;143A(13):1408–13.
Spiridigliozzi, Gail A., et al. “Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series.Am J Med Genet A, vol. 143A, no. 13, July 2007, pp. 1408–13. Pubmed, doi:10.1002/ajmg.a.31790.
Spiridigliozzi GA, Heller JH, Crissman BG, Sullivan-Saarela JA, Eells R, Dawson D, Li J, Kishnani PS. Preliminary study of the safety and efficacy of donepezil hydrochloride in children with Down syndrome: a clinical report series. Am J Med Genet A. 2007 Jul 1;143A(13):1408–1413.
Journal cover image

Published In

Am J Med Genet A

DOI

ISSN

1552-4825

Publication Date

July 1, 2007

Volume

143A

Issue

13

Start / End Page

1408 / 1413

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Piperidines
  • Male
  • Indans
  • Humans
  • Female
  • Drug Administration Schedule
  • Down Syndrome
  • Donepezil
  • Cognition