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Piracetam Therapy Does Not Enhance Cognitive Functioning in Children With Down Syndrome
Nancy J. Lobaugh, PhD;
Vladimir Karaskov, MD;
Vicki Rombough, MA;
Joanne Rovet, PhD;
Susan Bryson, PhD;
Rachel Greenbaum, MA;
Robert H. Haslam, MD;
Gideon Koren, MD
Arch Pediatr Adolesc Med. 2001;155:442-448.
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.
From the Rotman Research Institute of Baycrest Centre for Geriatric
Care and University of Toronto (Dr Lobaugh); the Division of Clinical Pharmacology
and Toxicology (Drs Karaskov and Koren and Ms Greenbaum), the Department of
Psychology (Dr Rovet and Ms Greenbaum), and the Division of Neurology (Drs
Bryson and Haslam), The Hospital for Sick Children; the Departments of Paediatrics
(Drs Rovet and Haslam), Pharmacology (Dr Koren), Pharmacy (Dr Koren), Medicine
(Drs Lobaugh, Haslam, and Koren), and Psychology (Dr Rovet), University of
Toronto; and the Department of Psychology, York University (Ms Rombough and
Dr Bryson), Toronto, Ontario.
Corresponding author: Nancy J. Lobaugh, PhD, Imaging Research and
Cognitive Neurology Unit, Sunnybrook and Women's College Health Sciences Centre,
2075 Bayview Ave, Room S604, Toronto, Ontario, Canada M4N 3M5 (e-mail: nlobaugh{at}sten.sunnybrook.utoronto.ca).
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