Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216593
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2005-09-13
Brief Title:
Treatment of Severe Alzheimers Disease Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Treatment of Severe Alzheimers Disease in a Residential Home Nursing Home or Geriatric Residential Setting Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Randomised Doubleblind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2010-04
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 assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimers disease
Detailed Description:
This is a multicenter 1-year study that includes a randomized 6-month double-blind placebo-controlled phase and a 6-month open-label extension of galantamine hydrobromide treatment in subjects with severe Alzheimers disease The open-label extension is optional for al patients Patients eligible for the study will be randomized to treatment with either galantamine hydrobromide or placebo over 6 months for the first phase of the study The principal measures include the results of the Severe Impairment Battery and the Minimum Data Set-Activities of Daily Living tests to assess aspects of cognition and behavior and impact on the patients ability to perform normal daily activities Additional evaluations include the Neuro-Psychiatric Inventory-Nursing Home Version measure and 2 subscales of the Minimum Data Set tests to further assess patients behavior social and physical functioning the level of caregiver support needed and impact to the patients caregiver the Mini-Mental State Examination to assess cognitive abilities and external health-and social-service use Safety and tolerability will be evaluated on the basis of adverse event reports physical examination electrocardiograms vital signs and laboratory parameters The study hypothesis is that treatment with galantamine compared with placebo will significantly improve cognition and ability to function in patients with severe Alzheimers disease and is generally well-tolerated Galantamine hydrobromide tablets taken by mouth two times daily 4 weeks at 8 milligrams mgday 4 weeks at 16 mgday increased to 24 mgday for the remainder of the 6 months Dose may be reduced at investigators discretion Galatamine hydrobromide for additional 6 months in open-label phase
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