Phase 2 N=8 Randomized Quadruple-blind Treatment

Rivastigmine Study in Adolescents With Down Syndrome

Down Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01084135 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) — -1.7; 2.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rivastigmine (Drug); Liquid Placebo (Other)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)	-1.7; 2.0	—
SECONDARY Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)	-3.6; -6.1	—

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 Criteria

Inclusion Criteria

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

Exclusion Criteria

Subject uses sign language as a primary means of communication
Subject has a medical history that contraindicate the use of rivastigmine (For example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01084135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.