Phase 2
Completed N=8
Rivastigmine Study in Adolescents With Down Syndrome
Source: ClinicalTrials.gov NCT01084135 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) — -1.7; 2.0 units on a scale
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.
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 | — |
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).
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. Informational only — not medical advice.