Ignite Creation Date:
2025-12-18 @ 3:46 AM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT00748007
Status:
None
Last Update Posted:
2012-11-28 00:00:00
First Post:
2008-09-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Rivastigmine in Patients With Down Syndrome
Sponsor:
None
Organization:
Study Overview
Official Title:
Efficacy of Rivastigmine in Patients With Down Syndrome
Status:
None
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: