Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227994
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2005-09-26
Brief Title:
Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Donepezil Galantamine in the Treatment of Post-stroke Cognitively Impaired Rehabilitating Elderly
Status:
COMPLETED
Status Verified Date:
2017-11
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:
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors
Detailed Description:
Cognitive impairment is a common result of a stroke and can be detrimental to recovery It can negatively affect both mental and physical functioning thereby complicating the rehabilitation process Although much research has targeted the effects of long-term cognitive impairment after a stroke very little research has been done to examine the incidence and course of cognitive impairment during the first three months following a stroke These first three months are the most important in terms of regaining function Acetylcholinesterase inhibitors have been beneficial to both sufferers of vascular dementia and Alzheimers disease They may also be a useful pharmacologic intervention to enhance post-stroke rehabilitation This study will compare the effectiveness of two acetylcholinesterase inhibitors galantamine and donepezil in improving cognitive function and overall rehabilitation in elderly stroke survivors
Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks 8 mg twice a day for the next 4 weeks and 12 mg twice a day for the remainder of the study Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks and then 10 mg twice a day for the next 6 weeks Functional independence will be measured at baseline and Weeks 2 and 12 In addition a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families Participants will also be monitored for signs of depression and medication side effects throughout the study
Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks 8 mg twice a day for the next 4 weeks and 12 mg twice a day for the remainder of the study Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks and then 10 mg twice a day for the next 6 weeks Functional independence will be measured at baseline and Weeks 2 and 12 In addition a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families Participants will also be monitored for signs of depression and medication side effects throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH064196-01 | NIH | None | httpsreporternihgovquickSearchK23MH064196-01 |