Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301574
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2006-03-10
Brief Title:
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimers Disease
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
Placebo-Controlled Double-Blind Study of Galantamine R113675 in the Treatment of Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2011-01
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:
The purpose of this study is to evaluate the efficacy and safety of two fixed doses 16mgday and 24mgday of galantamine a drug for treating dementia versus placebo for the treatment of patients with Alzheimers disease and to investigate the dose-response
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine 16 and 24 milligrams per day mgday in patients with Alzheimers disease and to investigate the dose-response The study consists of a 4-week screening period during which all patients will receive placebo and a 22-week double-blind treatment period during which patients will receive placebo galantamine 16 mgday or galantamine 24 mgday For patients receiving galantamine treatment the starting dose is 8 mgday and increases at 4-week intervals in increments of 8 mgday The primary measures of effectiveness are the change from baseline to the end of the study week 22 in the Alzheimers Disease Assessment Scale - Japan cognitive subscale ADAS-J cog and the Clinicians Interview-Based Impression of Change plus - Japan CIBIC plus-J Safety assessments include the incidence of adverse events clinical laboratory tests vital signs electrocardiograms ECGs and physical examination findings The study hypothesis is that galantamine will be more effective in the treatment of Alzheimers disease than placebo Study drug taken orally twice a day 4-week screening period All patients receive placebo 22-week treatment period Patients receive placebo galantamine 16 mgday or 24 mgday For galantamine treatment the starting dose is 8 mgday and increases at 4-week intervals in increments of 8 mgday
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