Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006187
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2000-08-25
Brief Title:
The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimers Disease
Sponsor:
Merck Sharp Dohme LLC
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2003-10
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 is a 15-month study with two phases During the first 12-month phase of this study patients will be randomly assigned to receive either active study drug or placebo approximately half of all patients will be on active study drug the other half on placebo The second phase is a 3-month randomized withdrawal period For this phase approximately 10 of the patients will remain on the active drug
Detailed Description:
This is a placebo-controlled parallel-groups 12 month double-blind study followed by a 3-month double-blind randomized withdrawal period to evaluate the efficacy and safety of an investigational drug currently approved for other indications to slow the progression of symptoms of AD Patients with probable AD according to NINCDS-ADRDA criteria who have a Mini Mental State Examination MMSE score between 13 and 26 inclusive will be eligible for participation in the study
Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD except for tacrine for at least 3 months are eligible for study entry Use of NSAIDs except aspirin 81 mg per day is not allowed during the study
Patients on stable doses of marketed cholinesterase inhibitors approved for the treatment of AD except for tacrine for at least 3 months are eligible for study entry Use of NSAIDs except aspirin 81 mg per day is not allowed during the study
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?: