Results. Eighteen children (7 - 13 yrs) completed the study, 5 withdrew, and 2 could not complete the battery at baseline testing. The mean mental age for the final sample was 4.2 ± .7 years (Stanford Binet). The 16 tasks yielded 75 measures and the parent and teacher questionnaires had 80 and 24 items, respectively. Piracetam did not show significant effects over placebo on any outcome measure (ANCOVA, covariate was age at baseline). All significant interactions (p's < 0.05) with drug order or the covariate were examined further to ensure drug effects were not being masked. That analysis did not alter the results. Piracetam administration was associated with CNS stimulatory effects: aggressiveness (n=4), agitation (n=3), sexual arousal, (including masturbation in public, n=2), irritability (n=1), and poor sleep (n=1).

Conclusion. Piracetam has received a great deal of attention in the popular press purporting its efficacy in improving cognitive function in children with Down Syndrome. In this study, we were unable to substantiate these claims, even at doses associated with adverse effects. Neither cognitive nor behavioural measures demonstrated improvement under piracetam. Due to the serious adverse effects, it is unlikely that larger doses can be tolerated.