Clinical Trial: Efficacy of Rivastigmine in Patients With Down Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Rivastigmine in Patients With Down Syndrome

Brief Summary: This study is to understand the efficacy on language and cognitive function in Down syndrome patients who take Rivastigmine.

Detailed Summary: 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 dementia is known to be related with APP gene dosage triplication that is similar to the neuropathological change in Alzheimer disease (AD). It has been known that the cognitive degeneration in AD is related with decrement of cholinergic neurons in the brain. And the clinical improvement or delay in degeneration of cognitive function after utilization of cholinesterase inhibitor had been observed in mild to moderate AD patients. In DS brain, it has been also noted to be lower acetylcholine, supporting the relationship of pathology between DS and AD. Since 1999, Kishnani et al started to treat adult DS patients with cholinesterase inhibitor (Donepezil). Data showed the improvement of cognition and life quality in DS patients with dementia. Recently, data showed the low cholinergic neuron in DS brain might be a cause of cognitive dysfunction in DS. Therefore, early treatment of cholinesterase inhibitor in DS patients had been proposed to alleviate cognitive dysfunction. Since 2004, Kishnani et al started to treat DS children with Donepezil and Rivastigmine. Some patients showed improvement of language ability, memory, and attention. We are going to conduct a randomized, double-blind, placebo-controlled, crossover design, 12-month trial. Subjects who are enrolled in this study will be randomized into two groups. Each group will receive Rivastigmine and placebo in different order for 6 months. Neuropsychological assessment including Vineland Adaptive Behavior Scales and NEPSY will be evaluated before and after medication. Through this, we wish to understand the efficacy of this drug in the role of improving cognitive functioning in our patients.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: Scores of Vineland Adaptive Behavior Scales (VABS), Scores of WISC digit span, Scores of Leiter-R Forward memory , Scores of PPVT, [ Time Frame: at 24, and 54 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Scores of NEPSY test for Visuospatial and Design Coping, Scores of Visuomotor Precision, Scores of WPPSI Sentences, Scores of Score for Character Recognitions by School Grade, and Scores of Test for Mathematic Ability for Children [ Time Frame: 24 and 54 wks ]

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: September 5, 2008
Date Started: January 2008
Date Completion:
Last Updated: November 27, 2012
Last Verified: November 2012