Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000172
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-29
Brief Title:
Evaluation of Galantamine in the Treatment of Alzheimers Disease
Sponsor:
Janssen LP
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimers Disease Safety and Efficacy Under a Slow-Titration Regimen
Status:
COMPLETED
Status Verified Date:
2002-11
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:
Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimers disease Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimers disease It is not a cure for Alzheimers disease Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine
Detailed Description:
After a 1-month single-blind run in phase 910 subjects will be titrated over a period of up to 8 weeks to target doses of either 0 placebo 24 mgday galantamine 16 mgday galantamine or 8 mgday galantamine in a 2221 randomization ratio Double-blind treatment will continue for a total of 5 months The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints Tolerability will be evaluated based on adverse event reports laboratory values ECG and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mgday Efficacy of 24 mgday and 16 mgday galantamine will be compared with that of placebo Information on the dose response relationship of galantamine will be evaluated
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?: