Rivastigmine Study in Adolescents With Down Syndrome

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.

Inclusion Criteria:

1. Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test
items.

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

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

4. Subjects are in good health and medically stable

Exclusion Criteria:

1. Subject uses sign language as a primary means of communication

2. 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).