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The NDSC cannot
recommend the use of piracetam for people with Down syndrome
because there are no scientific studies proving its effectiveness
and because there are concerns about adverse reactions.
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"Piracetam"
is a cyclic derivative of gamma-aminobutyric acid
(GABA), and a representative of what are commonly
known as the "nootropic" drugs. It is
manufactured overseas by several companies, and
marketed in Europe, Mexico, and South America. It
does not have Federal Drug Administration approval
for any use, and does not appear in the Physicians
Desk Reference. It is easily available over the
internet where many claims about its usefulness
in a variety of settings are made.
There
have been few studies reported in the scientific
literature on the use of piracetam in children with
Down syndrome.
The studies that have been reported are: |
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| 1. |
Archives of Pediatric
and Adolescent Medicine, in April 2001, published
an article by Lobaugh, NJ, Karaskov V, Rombough
V, et al., titled "Piracetam Therapy
Does not Enhance Cognitive Functioning in
Children with Down Syndrome." This was
a randomized, double-blind, placebo controlled,
cross-over study. The 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), poor sleep (n=1), and
decreased appetite (n=1)." |
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| 2. |
In Physiology of Behavior in
November 2002, Moran TH, and Capone GT, et
al., published a paper with the title "The
effects of Piracetam on Cognitive Performance
in a Mouse Model of Down's Syndrome."
Ts65Dn mice have a trisomic area of mouse
chromosome 16 that is analogous to human chromosome
21. The different sets of treatment mice were
given either 0, 75, 150, or 300 mg/kg of piracetam
during a 4 week period. The authors concluded
"In summary, these data do not provide
support for piracetam therapy to improve cognitive
performance in children with DS. Although
there was some small improvement in the visible-platform
component of the Morris water maze task with
low-dose piracetam treatment, piracetam prevented
learning in the more complex hidden-platform
component. Together with recent clinical data,
these results using a preclinical model with
many genetic and behavioral features of DS
provide no rationale for piracetam treatment
in children with DS." |
Please quote fully and reference National Down Syndrome
Congress. Adopted by Board of Directors, May
12, 2004.
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