Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253227
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-11-10
Brief Title:
A Study of the Safety and Effectiveness of a Flexible Dose of Galantamine Versus Placebo in the Treatment of Patients With Alzheimers Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Galantamine in the Treatment of Alzheimers Disease Flexible Dose Range Trial
Status:
COMPLETED
Status Verified Date:
2010-11
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 safety and effectiveness of galantamine a drug for treating dementia versus placebo in the treatment of patients with Alzheimers disease using a flexible dose design
Detailed Description:
Dementia is a chronic progressive brain disease that may involve a number of symptoms including memory loss and changes in personality behavior judgment attention span language and thought The most common type of dementia is Alzheimers disease Over time patients with Alzheimers disease may lose ability to perform daily tasks related to personal care for example bathing dressing eating and may be unable to handle money or travel to familiar places Several small clinical trials have shown galantamine to be safe and effective in treating the symptoms associated with Alzheimers disease Doses studied have ranged from 225 - 45 mgday with galantamine administered two or three times daily Additional information is needed to determine the optimal dose regimen for galantamine in the treatment of Alzheimers disease This multicenter double-blind placebo-controlled neither the patient nor the study doctor know the dose of galantamine being given study evaluates the safety and effectiveness of galantamine in the treatment of patients with Alzheimers disease using a flexible dose regimen of two doses of galantamine The flexible dose regimen was chosen in order to allow the physicians to give each patient an optimal dose of galantamine to simulate what might be done in clinical practice rather than to require all patients to receive a fixed dose throughout the study All patients initially receive placebo for a 1-month period and then receive one of two doses of galantamine beginning with 4 mg twice daily and gradually increasing to 12 or 16 mg twice daily or placebo for 3 months The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog11 score Alzheimers Disease Assessment Scale sum of 11 cognitive items and the CIBIC-plus score Clinicians Interview Based Impression of Change - Plus Caregiver Input Additional measures of effectiveness assessed at the end of the treatment include the ADAS-cog13 score Alzheimers Disease Assessment Scale sum of 13 cognitive items the Disability Assessment for Dementia DAD score and the Neuropsychiatric Inventory NPI score Safety evaluations incidence of adverse events quality of sleep using the Pittsburgh Sleep Scale electrocardiograms ECGs physical examinations laboratory tests are performed throughout the study Blood samples are taken throughout the study to determine the concentration of drug in the blood Patients who complete this study will have the option to receive open-label galantamine in a separate study The study hypothesis is that galantamine administered in either dose is effective in the treatment of Alzheimers disease as compared with placebo and well tolerated and that using a flexible dose regimen will allow these patients to receive an individualized dose of galantamine that is effective and well tolerated Galantamine tablets or placebo 12 or 16 mg by mouth twice daily for 3 months beginning with 4 mg twice daily and gradually increasing to 12 or 16 mg twice daily
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