Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322153
Status:
COMPLETED
Last Update Posted:
2010-09-16
First Post:
2006-05-03
Brief Title:
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimers Disease
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimers Type
Status:
COMPLETED
Status Verified Date:
2010-08
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 objective of this study is to evaluate the safety tolerability and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimers type on a concurrent acetylcholinesterase inhibitor AChEI
Detailed Description:
Memantine is a therapeutic agent that represents a unique class of Alzheimers disease AD treatment options A once daily QD dosing regimen in an AD population would simplify administration for the caregiver The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI
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