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


METHODS
A randomized, double-blind, placebo-controlled crossover study.


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.


METHODS
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).


CONCLUSIONS
Piracetam therapy did not enhance cognition or behavior but was associated with adverse effects.
Lobaugh
N J
NJ
Imaging Research and Cognitive Neurology Unit, Sunnybrook and Women's College Health Sciences Centre, 2075 Bayview Ave, Room S604, Toronto, Ontario, Canada M4N 3M5. nlobaugh@sten.sunnybrook.utoronto.ca
Karaskov
V
V
Rombough
V
V
Rovet
J
J
Bryson
S
S
Greenbaum
R
R
Haslam
R H
RH
Koren
G
G
D000293:Adolescent; D000704:Analysis of Variance; D002648:Child; D003071:Cognition / Q000187:drug effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004314:Down Syndrome / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008607:Intellectual Disability / Q000188:drug therapy* / Q000209:etiology; D018697:Nootropic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D010889:Piracetam / Q000494:pharmacology / Q000627:therapeutic use*
D018697:Nootropic Agents; D010889:Piracetam