CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Rivastigmine +1 moredrug
Likely dose
Rivastigmine 0.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01084135
NCT01084135Phase 2Completed
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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

Duke University·interventional·Posted Mar 10, 2010·Updated Apr 6, 2015

In Brief

A Phase 2 clinical trial evaluating Rivastigmine and Liquid Placebo for Down Syndrome. Completed, enrolled 42 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome
CountriesUnited States
CollaboratorsTaishoff Family Foundation, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 10, 2010
Enrollment StartNov 1, 2009
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.3 years ago

Interventions

Rivastigminedrug

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.

Liquid Placeboother

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.