Down Syndrome Clinical Trial
Official title:
A 20-Week Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Rivastigmine in Children (Ages 10-18) With Down Syndrome
The purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with Down syndrome.
This 24 week, double-blind, placebo controlled trial will be completed at the Clinical
Research Unit of Duke University Medical Center and at the Kennedy Krieger Institute (KKI).
Sixteen evaluable subjects will be enrolled at Duke and 24 evaluable subjects will be
enrolled at KKI. The study consists of four visits, a screening visit (-4 weeks), a baseline
visit (week 0); a safety visit at week 10, and a final/termination visit at week 20.
The specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate
treatment; b) build upon our open-label treatment results of overall function and language
improvement in adolescents with Down syndrome (DS) in a double-blind, placebo-controlled
clinical trial; and c) investigate other specific cognitive domains that may selectively
respond to rivastigmine tartrate treatment.
The original IRB-approved protocol included the Parent/Caregiver Rating Form of the Vineland
Adaptive Behavior Scales- Second Edition (VABS-II) . The protocol was amended to replace the
Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition
(VABS-II) with the Vineland Adaptive Behavior Scales, Second Edition, Survey Interview Form.
The protocol was also amended to extend the trial from 12 weeks to 20 weeks. Due to the
changes in the amended protocol the subject enrolled prior to the IRB amendment will not be
included in the data analysis section.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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