Piracetam therapy does not enhance cognitive functioning in children with down syndrome

Arch Pediatr Adolesc Med. 2001 Apr;155(4):442-8. doi: 10.1001/archpedi.155.4.442.


Background: Piracetam is widely used as a purported means of improving cognitive function in children with Down syndrome. Its efficacy, however, has not been rigorously assessed.

Objective: To determine whether 4 months of piracetam therapy (80-100 mg/kg per day) enhances cognitive function in children with Down syndrome.

Design: A randomized, double-blind, placebo-controlled crossover study.

Participants and methods: Twenty-five children with Down syndrome (aged 6.5-13 years) and their caregivers participated. After undergoing a baseline cognitive assessment, children were randomly assigned to 1 of 2 treatment groups: piracetam-placebo or placebo-piracetam.

Main outcome measure: The difference in performance while taking piracetam vs while taking placebo on tests assessing a wide range of cognitive functions, including attention, learning, and memory.

Results: Eighteen children completed the study, 4 withdrew, and 3 were excluded at baseline. Piracetam therapy did not significantly improve cognitive performance over placebo use but was associated with central nervous system stimulatory effects in 7 children: aggressiveness (n = 4), agitation or irritability (n = 2), sexual arousal (n = 2), poor sleep (n = 1), and decreased appetite (n = 1).

Conclusion: Piracetam therapy did not enhance cognition or behavior but was associated with adverse effects.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Analysis of Variance
  • Child
  • Cognition / drug effects*
  • Cross-Over Studies
  • Double-Blind Method
  • Down Syndrome / complications
  • Down Syndrome / drug therapy*
  • Humans
  • Intellectual Disability / drug therapy*
  • Intellectual Disability / etiology
  • Nootropic Agents / pharmacology
  • Nootropic Agents / therapeutic use*
  • Piracetam / pharmacology
  • Piracetam / therapeutic use*


  • Nootropic Agents
  • Piracetam