Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01380288
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2011-06-21
Brief Title:
Cognitive Changes in Alzheimers Disease Patients Associated With or Without White Matter Changes After Rivastigmine
Sponsor:
Dong-A University
Organization:
Dong-A University
Study Overview
Official Title:
Changes of Cognitive Function in Patients With Mild to Moderate Alzheimers Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center Prospective Open-label Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-02
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:
CAREER
Brief Summary:
The purpose of this study is to evaluate and compare the changes of cognitive function as measured by ADAS-Cog in the two group of patients with Alzheimers disease AD associated with and without white matter changes after rivastigmine patch therapy
Detailed Description:
Acetylcholinesterase inhibitors AChEIs increase the amount acetylcholine at ACh receptors within the brain and are the primary medications used to treat AD Alzheimers disease patients are frequently associated with mild or moderate white matter changes on MR imaging The impact of whiter matter changes on the efficacy of cognition functional abilities behavioral and psychiatric symptoms and caregiver burden for probable Alzheimers disease is not well known There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimers disease associated with or without vascular risk factors
Recently the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules with markedly improved tolerability profile The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimers and vascular pathologies contributing to dementia providing additive treatment effects in patients suffering from both conditions concurrently To our Knowledge there was no study or clinical trial to compare the changes of cognitive function ADL BPSD and caregiver burden in two groups of patient with Alzheimers disease associated with or without white matter changes after rivastigmine transdermal patch therapy
Recently the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules with markedly improved tolerability profile The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimers and vascular pathologies contributing to dementia providing additive treatment effects in patients suffering from both conditions concurrently To our Knowledge there was no study or clinical trial to compare the changes of cognitive function ADL BPSD and caregiver burden in two groups of patient with Alzheimers disease associated with or without white matter changes after rivastigmine transdermal patch therapy
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?:
None