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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: No
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• Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test items.

• Subject able to put at least 2-3 words together in conversational speech.

• Subject's speech is understandable to the examiner for the majority of the time.

• Subjects are in good health and medically stable

Locations
United States
Maryland
Kennedy Krieger Institute
Baltimore
North Carolina
Duke University Medical Center
Durham
Time Frame
Start Date: November 2009
Completion Date: February 2014
Participants
Target number of participants: 42
Treatments
Experimental: Rivastigmine- Liquid form
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. 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.
Placebo Comparator: Liquid placebo
Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
Related Therapeutic Areas
Sponsors
Collaborators: Taishoff Family Foundation, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Leads: Duke University

This content was sourced from clinicaltrials.gov