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  Vol. 155 No. 4, April 2001 TABLE OF CONTENTS
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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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Child Advocacy and Robust Community-Centered Research
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Arch Pediatr Adolesc Med. 2001;155(4):438-439.
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Piracetam Therapy for Down Syndrome: A Rush to Judgment?
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Arch Pediatr Adolesc Med 2001;155:1176-1176.
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Arch Pediatr Adolesc Med 2001;155:1176-1178.
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AAP News 2001;18:246-246.
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Child Advocacy and Robust Community-Centered Research
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Arch Pediatr Adolesc Med 2001;155:438-439.
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