Clinical Trial: Rivastigmine Study in Adolescents With Down Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Duke University
Current Primary Outcome: Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) [ Time Frame: Baseline & Study termination (Week 20) ]
Original Primary Outcome: Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) [ Time Frame: Baseline & Study termination (Week 20) ]
Current Secondary Outcome: Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) [ Time Frame: Baseline and Final (Week 20) visit ]
Original Secondary Outcome: Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) [ Time Frame: Baseline and Final (Week 20) visit ]
Information By: Duke University
Dates:
Date Received: March 8, 2010
Date Started: November 2009
Date Completion:
Last Updated: March 17, 2015
Last Verified: February 2015