Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00253214
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-11-10
Brief Title:
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimers Disease Safety and Efficacy of a Controlled-Release Formulation
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimers Disease Safety and Efficacy of a Controlled-Release Formulation
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 a once daily controlled-release form of galantamine a drug for treating dementia versus placebo in the treatment of patients with Alzheimers disease
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 the ability to perform daily tasks related to personal care for example bathing dressing and eating and may be unable to handle money or travel to familiar places Previous clinical trials have shown that a twice-daily dose of galantamine 18 - 32 mgday improved symptoms of Alzheimers disease This multicenter double-blind placebo-controlled study evaluates the safety and effectiveness of a controlled-release form of galantamine in patients with Alzheimers disease All patients receive placebo during the first month of the study Patients then receive controlled-release galantamine 8 - 24 mg once daily or immediate-release galantamine 4 - 12 mg twice daily or placebo for 6 months The dose of galantamine starts at 8 mgday and may be increased up to 24 mgday if needed The dose may be adjusted up or down during the first 12 weeks of double-blind treatment based upon effectiveness and tolerability Patients continue to receive the dose they are taking at the end of 12 weeks for the remainder of the study The primary measures of effectiveness include the change from baseline to the end of treatment in the ADAS-cog11 Alzheimers Disease Assessment Scale sum of 11 cognitive items and CIBIC-plus Clinicians Interview Based Impression of Change - Plus Caregiver Input scores Additional measures of effectiveness include the change from baseline in the Alzheimers Disease Cooperative Study - Activities of Daily Living ADCS-ADL and the Neuropsychiatric Inventory NPI scores Safety evaluations incidence of adverse events electrocardiograms ECGs physical examinations laboratory tests are performed throughout the study Patients who complete the double-blind portion of the study have the opportunity to receive galantamine in an open-label follow-up study Patients may also participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies The study hypothesis is that treatment with controlled-release galantamine is effective in improving the symptoms of Alzheimers disease and is well tolerated Controlled-release galantamine 8 - 24 mg by mouth once daily or immediate-release galantamine 4 - 12 mg by mouth twice daily or placebo Dosing starts at 8 mgday and may be increased up to 24 mgday if needed The study duration is 6 months
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