Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105105
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2005-03-04
Brief Title:
Mifepristone as Adjunctive Therapy in Alzheimers Disease
Sponsor:
Corcept Therapeutics
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Double-blind Placebo-controlled Trial of the Safety and Efficacy of C-1073 Mifepristone as Adjunctive Therapy in Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 effects of C-1073 Mifepristone on cognition in patients with Alzheimers disease AD who are also taking an acetylcholinesterase inhibitor Aricept Exelon or Reminyl
Detailed Description:
This will be a double blind placebo controlled study of C-1073 to evaluate the effects on cognition in patients with mild to moderate Alzheimers disease who are already receiving an acetylcholinesterase inhibitor and have been on a stable dose for at least 12 weeks Patients will be randomized 11 to either daily dosing with 300 mg C-1073 or a placebo for 16 weeks Patients will continue the stable daily dose of acetylcholinesterase inhibitor throughout the study
Visits will be weekly at the beginning of the study then every two weeks and every 4 weeks after week 12 Assessments during these visits may include cognition and behavior depression safety as well as physical exams clinical laboratory tests EKG and adverse event reporting
Visits will be weekly at the beginning of the study then every two weeks and every 4 weeks after week 12 Assessments during these visits may include cognition and behavior depression safety as well as physical exams clinical laboratory tests EKG and adverse event reporting
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