Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062972
Status:
WITHDRAWN
Last Update Posted:
2017-04-25
First Post:
2003-06-18
Brief Title:
Improving Memory in Patients With Multiple Sclerosis
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Interventions to Improve Memory in Patients With Multiple Sclerosis
Status:
WITHDRAWN
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminatedwithdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with multiple sclerosis MS suffer from cognitive and other brain problems This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS Donepezil also known as Aricept has been FDA approved for improving memory and learning in individuals with Alzheimers disease
Detailed Description:
Cognitive dysfunction is one of the leading causes of disability in people with MS Memory involving specific words verbal memory is particularly affected in individuals with MS Attempts to rehabilitate cognitive dysfunction in MS have had only limited success
This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS The study will also measure secondary outcomes assessing other areas of cognitive dysfunction ie nonverbal memory conceptual thinking processing speed which may improve with intervention
Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks Participants will complete memory and cognitive tests at the beginning and end of the 24 week period
Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin placebo Participants will then complete memory and other cognitive tests Two weeks later participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests
This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS The study will also measure secondary outcomes assessing other areas of cognitive dysfunction ie nonverbal memory conceptual thinking processing speed which may improve with intervention
Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks Participants will complete memory and cognitive tests at the beginning and end of the 24 week period
Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin placebo Participants will then complete memory and other cognitive tests Two weeks later participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests
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