Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000174
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-29
Brief Title:
Investigation Into Delay to Diagnosis of Alzheimers Disease With Exelon InDDEx
Sponsor:
Novartis
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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 phase IIIb trial is a prospective randomized double-blind placebo-controlled 36-month study comparing the length of time of progression from mild cognitive impairment MCI to a clinical diagnosis of Alzheimers disease AD in subjects taking Exelon vs placebo Exelon is currently under review with the US Food and Drug Administration as a treatment for Alzheimers disease The drug has been cleared for marketing in more than 40 countries for Alzheimers disease to date including all 15 member states of the European Union New Zealand Argentina Brazil and Mexico
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo Subjects assigned to Exelon will receive 15 to 60 mg bid twice daily 30 to 12 mgday for the majority of the study At every regular visit scheduled every three months patients will be given basic efficacy and safety assessments These assessments will include evaluation of adverse events vital signs activities of daily living and clinical staging scales to determine if the subject may have converted to dementia
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo Subjects assigned to Exelon will receive 15 to 60 mg bid twice daily 30 to 12 mgday for the majority of the study At every regular visit scheduled every three months patients will be given basic efficacy and safety assessments These assessments will include evaluation of adverse events vital signs activities of daily living and clinical staging scales to determine if the subject may have converted to dementia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: