Status:
COMPLETED
Efficacy of Rivastigmine in Patients With Down Syndrome
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Down Syndrome
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This study is to understand the efficacy on language and cognitive function in Down syndrome patients who take Rivastigmine.
Detailed Description
Down syndrome (DS) is the most common cause of mental retardation due to chromosome anomaly. Besides defects in cognition, DS patients after 30 yeas old will have early dementia. Etiology of early dem...
Eligibility Criteria
Inclusion
- Age more than 8 years old
- Diagnosed to have Down syndrome.
- Full IQ \> 40
- Patients and caregiver agreed and could participated in this trial
- Have to sign permit. If patient is less than 18 years old, inform consent should be singed by parents
Exclusion
- Known to be allergy to Rivastigmine
- 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
- 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)
- Not willing to cooperate with follow up programs
- Other conditions that doctors or investigators consider not suitable to enter this trial
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00748007
Start Date
January 1 2008
End Date
December 1 2009
Last Update
November 28 2012
Active Locations (1)
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1
Department of Medical Genetics, National Taiwan University Hospital
Taipei, Taiwan, 100