Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182845
Status:
COMPLETED
Last Update Posted:
2008-03-03
First Post:
2005-09-09
Brief Title:
Donepezil in the Prevention of Post-Operative Cognitive Decline
Sponsor:
Pfizer
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Preventing Post-Operative Cognitive Decline
Status:
COMPLETED
Status Verified Date:
2008-02
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:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility of using Donepezil to prevent post-operative cognitive decline POCD among individuals aged 65 and older who have a baseline mild cognitive impairment MCI and are undergoing elective hip or knee replacement
Detailed Description:
Up to 65 of elderly patients undergoing hip or knee surgery suffer from declining brain function known as post-operative cognitive decline POCD These individuals often stay in the hospital longer have more complications and are more likely to die Recent clinical studies have shown the potential benefit of enhancing the cholinergic system among patients with both Alzheimers disease and or vascular dementia Donepezil is currently being used to treat memory loss in patients with Alzheimers disease
This study will recruit 30 cognitively impaired adults aged 65 or older who are scheduled to have elective hip or knee replacement surgery at University Hospital Participants will be randomized to receive either a three to six week supply of Donepezil or a matching placebo approximately 4 weeks prior to surgery This study will evaluate the effect of Donepezil on delirium incidence and severity during hospitalization global cognitive function length of hospitalization site of discharge and adverse drug effects
All material to be collected will be from interviews questionnaires and medical chart review Some will be at baseline during hospitalization and 12 weeks post hospitalization and others will be daily during hospitalization The International Study of Post-Operative Cognitive Decline battery of tests will be used in assessment as will the CogHealth computerized battery
This study will recruit 30 cognitively impaired adults aged 65 or older who are scheduled to have elective hip or knee replacement surgery at University Hospital Participants will be randomized to receive either a three to six week supply of Donepezil or a matching placebo approximately 4 weeks prior to surgery This study will evaluate the effect of Donepezil on delirium incidence and severity during hospitalization global cognitive function length of hospitalization site of discharge and adverse drug effects
All material to be collected will be from interviews questionnaires and medical chart review Some will be at baseline during hospitalization and 12 weeks post hospitalization and others will be daily during hospitalization The International Study of Post-Operative Cognitive Decline battery of tests will be used in assessment as will the CogHealth computerized battery
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