A clinical trial to evaluate the safety and efficacy of rivastigmine in children and adolescents (ages 10-17) with Down Syndrome

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While it is known that adults with Down syndrome (DS) exhibit a notable cholinergic deficiency, it is unclear how early in life presynaptic cholinergic deterioration begins.  Acetylcholinesterase inhibitors (AchEIs) have been shown to improve attention, memory, and language function in adults with DS.  This 20-week double-blind, placebo-controlled clinical trial will examine the use of an AchEI called Rivastigmine in children and adolescents with DS to a) investigate short-term safety and efficacy of the drug, and b) determine whether improvement in memory, language and other cognitive functions is observed following treatment.  Results from this study will contribute to the body of evidence suggesting a role for AchEIs in the management of cognitive and language dysfunction in children & adolescents with DS.

This study has been approved by the Johns Hopkins Institutional Review Board, Protocol Number: NA_00003324, approved 4/10/08.

Funded by a Private Family Foundation

Principal Investigator: Dr. George Capone

Contact Information:  Marie Andachter, andachter@kennedykreiger.org, 443-923-7716

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Last revised 31-Jan-2010 by Steven Leber