Overview

Efficacy of Rivastigmine in Patients With Down Syndrome

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to understand the efficacy on language and cognitive function in Down syndrome patients who take Rivastigmine.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Cholinesterase Inhibitors
Rivastigmine
Criteria
Inclusion Criteria:

1. Age more than 8 years old

2. Diagnosed to have Down syndrome.

3. Full IQ > 40

4. Patients and caregiver agreed and could participated in this trial

5. Have to sign permit. If patient is less than 18 years old, inform consent should be
singed by parents

Exclusion Criteria:

1. Known to be allergy to Rivastigmine

2. Currently uncontrolled heart, gastrointestinal, renal or central nervous system
problems that could effect evaluation or compliance A. Heart rate less than 50/min B.
Patients has uncontrolled severe disease such as gastric ulcer, uncontrolled
hypothyroidism, vit B12 deficiency, severe renal or liver disease, diabetes, or asthma
C. Uncontrolled psychiatric disease D. Diagnosed to have primary neurodegenerative
disease such as Huntington's disease, uncontrolled seizure, delirium E. Hearing
defects or vision effect that will affect neuropsychiatric evaluations F. Pregnancy

3. Currently usage of special medications A. Toxic agents to major organs 4 weeks before
using Rivastigmine B. Taking drugs for psychiatric problems 4 weeks before using
Rivastigmine C. Taking Rivastigmine 6 weeks before entering the trial D. Taking other
acetylcholinesterase inhibitors such as Donepezil (Aricept)、Galantamine (Razadyne,
Razadyne ER)、Anticholinergic agents, such as diphenhydramine (Benadryl), oxybutynin
(Ditropan), or N-Methyl-D-Aspartate (NMDA) receptor antagonist such as Memantine
(Namenda)

4. Not willing to cooperate with follow up programs

5. Other conditions that doctors or investigators consider not suitable to enter this
trial