Rivastigmine Study in Adolescents With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

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 description: 
      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.
    

Intervention name(s): Rivastigmine; Liquid Placebo
Intervention type(s): Drug; Other
Intervention description(s): At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. Subjects receiving placebo will maintain the same schedule. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.; Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Other intervention name(s): Rivastigmine-Excelon
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinical trial; Down syndrome; adolescents; cognitive; rivastigmine